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Practitioner training · Medical device quality
ISO 13485:2016 Implementation Training
Part of the ISO 13485:2016 learning path → Step 3
Online training course to build a medical device quality management system that meets regulatory requirements and is ready for certification.
This practitioner training course covers implementing ISO 13485:2016: for every clause, what it asks for, how to put it in place for your own devices and regulatory requirements, what documented procedures and records it needs and how to check that it works. A maker of sterile infusion sets in Singapore runs through the course.
What you get
- 26 video modules
About 6 hours, with captions. Watch at your own pace on any device.
- Practice after every module
Short questions check your understanding before you move on.
- Final exam
Score at least 60% to receive the Certificate of Competence.
- Built by experts
Industry experts, domain specialist trainers and globally renowned auditors with 30+ years in ISO and GRC.
A certificate you can prove, and share
Verifiable certificate with a QR code anyone can scan, plus a digital badge to add to your LinkedIn profile.
See how verification works →Standard and editionISO 13485:2016
Last updated27 October 2026
Preview this course
Experience the learning
before you enrol.
Watch a sample from ISO 13485:2016 Implementation Training before you enrol.
ISO 13485:2016 Implementation TrainingSample
Learning outcomes
Knowledge you can put to work.
Connect the subject to the responsibilities and decisions people encounter in their roles.
- Document the QMS and its roles, and build the medical device file
- Control documents and records for the lifetime of the device
- Plan product realization with risk management, and control design and development
- Control purchasing, production, process validation, sterilization and traceability
- Handle feedback, complaints, reporting to regulatory authorities and nonconforming product
- Run CAPA, audits and management review, and plan for certification
Part of: Medical Device Quality and Risk Management Training
Part of: GMP & Medical Devices
Inside the course
A clear path through the essentials.
26 modules, 26 practice checkpoints, 7 practice exercises and a final exam. Video runtimes are approximate; allow additional time for the practice questions and the final exam. Modules marked optional can be skipped; the others are studied in any order.
Part 1Foundations: the standard, its language and structureApprox. 53 min
- Welcome: a QMS for medical devices14 min
Introduces ISO 13485:2016 and why device makers need a quality management system, in a training course following XYZ Ltd., a Singapore infusion set maker.
What this module covers
Opens with the question of how you know every device you shipped was made under control. Sets out the course: twenty-six modules in three parts, the seven steps used for each requirement, practice, written exercises and a final exam. Then covers the standard's purpose for regulatory purposes, who can use it, how it relates to the general quality standard, the 2016 edition with five changes, and what a working system gives a device business.
What you will be able to do
- Explain what ISO 13485:2016 is for and who can use it
- Describe how the standard relates to the general quality standard
- Name five changes made in the 2016 edition
Why it matters
When a hospital asks how you know every device was made under control, a working system lets you answer with records, not promises.
Practice: Practice: Welcome: a QMS for medical devices · 3 questions
- The language of the standard15 min
Explains the defined terms and key phrases of ISO 13485:2016, such as complaint, risk, as appropriate, shall and supply chain roles, and why they matter.
What this module covers
Starts with a nurse's phone call about a roller clamp, logged as a service request in one version and as a complaint in the other. Covers clause 2 and clause 3, the phrases as appropriate and documented, and the words shall, should, may and can. Then defines medical device, life-cycle, device family, manufacturer, importer, distributor, authorised representative, risk, complaint and labelling, with examples from XYZ Ltd. in Singapore and a warehouse in Sydney.
What you will be able to do
- Decide whether a report from a customer counts as a complaint
- Identify your role in the supply chain from what you do
- Read shall, should, may and can correctly in a requirement
Why it matters
Reading the standard with everyday meanings leads to missed complaints and the wrong role, so one definition can decide what you must do.
Practice: Practice: The language of the standard · 3 questions
- How the standard is built13 min
Shows how ISO 13485:2016 is built, the process approach, the roles you hold, what may be left out and how to run a gap assessment before writing documents.
What this module covers
Begins with the choice between renaming an old quality manual and first comparing current practice with every requirement. Covers the eight clauses and two annexes, the process approach, and how the roles of XYZ Ltd. in Singapore, an importer in Toronto and a contract moulder change the system. Explains exclusion of design controls and non-application, then the five-step gap assessment with example findings and a draft scope.
What you will be able to do
- Describe the structure of the standard and its process approach
- Decide what may be excluded or not applied, and record why
- Carry out a five-step gap assessment and draft a scope
Why it matters
Companies that find out where they stand first close the gaps that put devices at risk first, and this training course then builds only the documents needed.
Practice: Practice: How the standard is built · 3 questions
- Implementation practice: Gap assessment and scope statementabout 10 min
Part 2The requirements in the standard's own orderApprox. 338 min
- General requirements17 min
Covers general requirements of a medical device quality system: documented roles, risk-based process control, change, outsourcing and software validation.
What this module covers
Begins with a contract steriliser that changes how it loads its chamber without telling XYZ Ltd. Walks through the six parts of clause 4.1: the system and your roles, processes and the risk based approach, what each process needs, changes, outsourcing and software. Examples include a process card for bonding, a written quality agreement, a pump servicer in London and validation of a complaint database.
What you will be able to do
- Document your roles and the requirements for each market
- Control processes in proportion to the risk to the device
- Set up quality agreements and software validation
Why it matters
Outsourcing a process never outsources the responsibility, so control that follows the risk to the device lets you know about a supplier's change in time.
Practice: Practice: General requirements · 3 questions
- The quality manual and the medical device file14 min
Covers the documentation a medical device quality system must include, the quality manual and the medical device file kept for each device type or family.
What this module covers
Begins with an importer in Dubai asking for the documents that define XYZ Ltd.'s infusion sets. Covers what clause 4.2.1 lists, the layers of documents, the contents of the quality manual in clause 4.2.2, and the medical device file in clause 4.2.3 with its six kinds of content. Uses a file index, one-file-or-two for a tubing family, and a hospital bed maker in Toronto.
What you will be able to do
- List what the quality system documentation must include
- Draft a quality manual with scope, justifications and process interaction
- Build a medical device file index that points to controlled masters
Why it matters
If you cannot show how a device is defined and made, you cannot show it is under control, and a registration can be delayed by one old label.
Practice: Practice: The quality manual and the medical device file · 3 questions
- Implementation practice: A medical device file indexabout 8 min
- Control of documents and of records13 min
Explains document control and record control in a medical device quality system, including the eight document controls and how long records are kept.
What this module covers
Starts with an old printout left at one packing station of XYZ Ltd. Separates documents from records, then goes through the eight controls of clause 4.2.4, the five stages from create to withdraw, and a master list. For clause 4.2.5 it covers the six record controls, confidential health information, visible corrections, and the retention rule of the device lifetime and never less than two years.
What you will be able to do
- Apply the eight controls to a document and keep a master list
- Set record retention from the device lifetime and regulations
- Correct a record so the change stays visible
Why it matters
One old instruction can make a whole batch wrongly, and one missing record leaves a batch you cannot defend, so control keeps both under check.
Practice: Practice: Control of documents and of records · 3 questions
- Commitment, policy and objectives14 min
Covers what top management must do under ISO 13485:2016: commitment, customer focus, the quality policy, measurable quality objectives and system planning.
What this module covers
Opens with a quality objective that rewards shipping more infusion sets, and what it did to leak checks at XYZ Ltd. in Singapore. Covers the five ways top management shows commitment, customer focus, the five points a quality policy must meet and the word understood. Then looks at measurable objectives by function, a distributor in Dubai, a servicing company in London, and planning for changes such as a new ERP.
What you will be able to do
- Show top management commitment through evidence, not a signature
- Write a short quality policy that people can say in their own words
- Set measurable quality objectives tied to device safety or regulation
Why it matters
Objectives decide where people put their effort, so a sales target posted as a quality objective can let complaints rise while the numbers look good.
Practice: Practice: Commitment, policy and objectives · 3 questions
- Roles, representative and communication12 min
Explains responsibility and authority, the management representative and internal communication, so people know who may stop a shipment before it matters.
What this module covers
Opens with a night shift in sterile packing at XYZ Ltd. where a weak pouch seal is found and nobody is sure who may hold the batch. Covers clause 5.5.1 on defined authority, interrelation and independence, then the management representative of clause 5.5.2 with its three duties, examples from Toronto and Manila, and clause 5.5.3 on internal communication, including what the channels must carry.
What you will be able to do
- Define and document responsibilities, authority and independence
- Appoint a management representative with the three duties
- Set up communication that tells teams how the system is working
Why it matters
Authority that is clear before it is needed lets a supervisor hold a doubtful batch at night, and problems reach people who can pay to fix them.
Practice: Practice: Roles, representative and communication · 3 questions
- Management review: input and output13 min
Explains how to run a management review of a medical device quality system, with its twelve required inputs, recorded outputs and decisions with owners.
What this module covers
Begins with a six-monthly review at XYZ Ltd. in Singapore where rising clamp complaints were shown and nothing was decided. Covers the documented procedure and planned intervals of clause 5.6.1, the meaning of suitable, adequate and effective, and the twelve inputs of clause 5.6.2 grouped as field, checks, actions and change. Then the four groups of output in clause 5.6.3, with a review cycle and examples from Hong Kong and Sydney.
What you will be able to do
- Write a management review procedure with planned intervals
- Cover all twelve inputs, grouped as field, checks, actions and change
- Record outputs as decisions with an owner, a date and resources
Why it matters
A review is measured by its decisions, and minutes that say discussed leave a rising complaint trend with nobody responsible for it.
Practice: Practice: Management review: input and output · 3 questions
- Resources and human resources12 min
Covers providing resources and human resources: determining competence, closing gaps, checking training effectiveness in proportion to risk, and awareness.
What this module covers
Opens with a new cleanroom operator at XYZ Ltd. in Singapore who signs an attendance sheet and starts work alone. Covers clause 6.1 on determining then providing resources, and clause 6.2 on competence for anyone whose work affects product quality, including agency staff and night cleaners. Follows the cycle of determine, compare, act, evaluate and record, with a sterile packing operator profile, and examples from New York and Mumbai.
What you will be able to do
- Write a competence profile for a job affecting product quality
- Evaluate training with a check in proportion to the risk of the work
- Keep records of education, training, skills and experience
Why it matters
Attendance shows a person was in the room, while records of a checked competence show she can do the job, which protects the device.
Practice: Practice: Resources and human resources · 3 questions
- Infrastructure and work environment13 min
Covers infrastructure and its maintenance, the controlled work environment and contamination control for medical devices, including sterile devices.
What this module covers
Opens with a cleanroom pressure monitor at XYZ Ltd. in Singapore that stopped recording for ten days while nine batches were packed. Covers clause 6.3 on documented infrastructure, preventing mix-up and maintenance with intervals, then clause 6.4.1 on the work environment, rules for health, cleanliness and clothing, clause 6.4.2 on contaminated product, and sterile devices. Examples include a distributor in Manila and a pump servicer in London.
What you will be able to do
- Document infrastructure and maintenance requirements with intervals
- Monitor and control a work environment that affects product
- Plan for contaminated product and sterile device cleanliness
Why it matters
A device is made right only under conditions you can show, so a monitor that stops recording unnoticed can leave you with no evidence for nine batches.
Practice: Practice: Infrastructure and work environment · 3 questions
- Planning realization and risk management15 min
Covers planning of product realization and the documented risk management process that links design, purchasing, production and feedback for a medical device.
What this module covers
Begins with XYZ Ltd. launching an infusion set with a finer flow clamp when the only plan is a launch date. Covers the four points of clause 7.1, what planning must determine, and as appropriate. Then risk as defined in clause 3, the outline of ISO 14971, the thread of risk through the standard, a sealer risk record, and when to revisit the plan, with a pump servicer in Sydney.
What you will be able to do
- Plan product realization with requirements, checks, criteria and records
- Document a risk management process and keep its records
- Connect the risk file to purchasing, design, production and complaints
Why it matters
A risk file can be excellent and still fail the patient if purchasing and production never read it, so the plan carries the risks into every process.
Practice: Practice: Planning realization and risk management · 3 questions
- Implementation practice: Outline your risk management process for product realizationabout 8 min
- Customer-related processes12 min
Explains how to determine and review customer requirements before accepting a medical device tender or order, and how to plan communication with customers.
What this module covers
Begins with XYZ Ltd. in Singapore bidding on a hospital tender for sets not yet registered in that country. Covers the five sources of requirements in clause 7.2.1, including user training, and the review before commitment in clause 7.2.2 with its records and confirmation of phone orders. Then clause 7.2.3 on planned communication about product information, orders, feedback and advisory notices, with examples from Dubai, Toronto and Hong Kong.
What you will be able to do
- List the five sources of product requirements
- Review requirements and record the result before you commit
- Document how you communicate about orders, feedback and advisory notices
Why it matters
Saying yes only to what you can deliver protects both the order and the distributor, because a review done after acceptance cannot change the answer.
Practice: Practice: Customer-related processes · 3 questions
- Design and development: plan, inputs, review16 min
Covers design and development controls for medical devices: the procedure, planning, verifiable inputs, outputs and design reviews, and who may exclude them.
What this module covers
Opens with a hospital bed maker in Toronto whose side rail fails with gloved nurses. Covers clause 7.3.1, who needs design controls and when they are not applicable, and outsourced design under a quality agreement. Then planning with six documented items and a traceability matrix, inputs in clause 7.3.3 including risk management outputs, outputs in clause 7.3.4, and design review records in clause 7.3.5, using XYZ Ltd. in Singapore.
What you will be able to do
- Plan a design project with stages, reviews and traceability
- Write design inputs that can be verified, not vague wishes
- Hold and record design reviews with the right functions present
Why it matters
A design error reaches every device you make and costs the most to fix after release, so inputs and reviews catch it while it is cheap.
Practice: Practice: Design and development: plan, inputs, review · 3 questions
- Design and development: verify to files16 min
Covers design verification and validation, design transfer to manufacturing, control of design changes and the design and development file for a medical device.
What this module covers
Opens with a patient monitor maker in New York whose slimmer battery fails on the charging dock. Separates verification, did we build it right, from validation, did we build the right thing, then covers clause 7.3.6 to clause 7.3.10: connected devices, clinical and performance evaluation, validation on initial production units, transfer, significance of changes, and the design file. Examples from XYZ Ltd., Sydney and Manila.
What you will be able to do
- Plan verification and validation with methods and acceptance criteria
- Validate on representative production units, not prototypes
- Judge, review and approve every design change and keep the file
Why it matters
A design can meet every verification and still fail validation, and no change is too small to review before it reaches the market.
Practice: Practice: Design and development: verify to files · 3 questions
- Purchasing: suppliers and checks14 min
Explains purchasing for medical device makers: choosing suppliers by risk, monitoring them, sending purchasing information and verifying what arrives.
What this module covers
Begins with a blood collection tube maker in Mumbai whose supplier quietly switched to a cheaper rubber. Covers purchased product, supplier criteria proportionate to risk in clause 7.4.1, monitoring and re-evaluation, outsourced processes under written quality agreements, and purchasing information in clause 7.4.2 with a change notification clause. Then verification in clause 7.4.3, with a resin purchase order from XYZ Ltd. and examples from Dubai and Toronto.
What you will be able to do
- Grade suppliers by their effect on the device and its risk
- Write purchasing information with a change notification clause
- Verify purchased product in proportion to supplier results and risk
Why it matters
Much of every device is bought in, and a certificate on file is a start, not a control: hear about a change before your device does.
Practice: Practice: Purchasing: suppliers and checks · 3 questions
- Production control and sterile devices15 min
Explains controlling production and service provision for medical devices: batch records, cleanliness, installation, servicing and records for sterile devices.
What this module covers
Begins with a catheter maker in Sydney whose two sizes ran on one line without clearing it. Covers the six controls and the record for each batch under clause 7.5.1, cleanliness of product in clause 7.5.2, installation in clause 7.5.3, servicing records treated as possible complaints in clause 7.5.4, and sterile device records in clause 7.5.5. Uses XYZ Ltd.'s cleanroom line, a distributor in Hong Kong and a bed installer in Dubai.
What you will be able to do
- Apply the six production controls and keep a batch record
- Decide which cleanliness cases apply to your product
- Link sterilisation load records to each production batch
Why it matters
Control the process, not just the product: a record made at the step, by the person doing the work, gives every unit a story you can tell.
Practice: Practice: Production control and sterile devices · 3 questions
- Process validation and sterilisation14 min
Explains process validation for production and service, including software, sterilisation and sterile barrier systems, and when a process must be revalidated.
What this module covers
Opens with a contract manufacturer in Toronto that replaced a worn ultrasonic welder and restarted with the same settings. Covers which processes need validation under clause 7.5.6, with four XYZ Ltd. processes sorted, the contents of a validation procedure, sample size rationale, revalidation criteria and software. Then clause 7.5.7 on sterilisation and the sterile barrier system, including an outsourced steriliser, a moulder in Mumbai and a London service company.
What you will be able to do
- Decide whether a process needs validation or can be verified
- Write revalidation criteria and check changes against them
- Validate the sterile barrier sealing process and review a steriliser's report
Why it matters
When nobody can see a defect until the device is in use, proven and recorded process limits are the only control, and they must stay current.
Practice: Practice: Process validation and sterilisation · 3 questions
- Identification and traceability14 min
Covers identification and product status, traceability to the extent regulations require, customer property and preservation of product for medical devices.
What this module covers
Opens with an orthopaedic screw maker in London that can trace a cracked screw to one material lot. Covers clause 7.5.8 on identification, status labels, unique device identification and returned devices, clause 7.5.9 on traceability, including implantable devices and distributor records, clause 7.5.10 on customer property, and clause 7.5.11 on preservation. XYZ Ltd. shows its trace chain, with a distributor in Hong Kong.
What you will be able to do
- Identify product status so only released product is dispatched
- Define the extent of traceability and test it backward and forward
- Safeguard customer property and preserve product under expected hazards
Why it matters
Traceability decides how many devices you look for when one fails, so testing the chain before a recall does keeps the search short.
Practice: Practice: Identification and traceability · 3 questions
- Implementation practice: Controls and records from purchasing to release for one productabout 10 min
- Monitoring and measuring equipment11 min
Explains control of monitoring and measuring equipment: choosing instruments, calibration to traceable standards and what to do when a gauge is found wrong.
What this module covers
Begins with a syringe maker in Manila whose force gauge was found reading wrongly with no record of which batches it tested. Covers clause 7.6: starting from the measurement the product needs, the five controls of calibration, adjustment, identification, safeguarding and protection, and the look-back at earlier results when equipment is out of tolerance. Also software that measures, with XYZ Ltd.'s pull tester and examples from New York and Toronto.
What you will be able to do
- Choose equipment from the measurement the product needs
- Control calibration, status labels, adjustment and protection
- Assess and record earlier results when equipment is found wrong
Why it matters
A result is only as good as the instrument behind it, and naming the instrument on each record keeps a faulty gauge from holding up every batch.
Practice: Practice: Monitoring and measuring equipment · 3 questions
- Feedback, complaints and reporting16 min
Covers how clause 8 begins, then feedback, complaint handling and reporting to regulatory authorities, including what counts as a complaint.
What this module covers
Opens with three calls about a cracked drip chamber to an importer in Dubai, handled as returns in one version and as complaints in the other. Covers the planning of measurement and analysis in clause 8.1, feedback in clause 8.2.1 and post-market surveillance, the definition of a complaint, the six points of clause 8.2.2, and reporting to regulators in clause 8.2.3 with advisory notices. Includes XYZ Ltd.'s complaint record.
What you will be able to do
- Decide whether a report is a complaint using the standard's definition
- Write a complaint procedure covering the six points of clause 8.2.2
- Record reporting decisions with reasons, taking limits from the regulations
Why it matters
Every complaint is a signal, and a recorded decision with its reasons lets you explain yourself when a regulator asks.
Practice: Practice: Feedback, complaints and reporting · 3 questions
- Implementation practice: Handle one complaint and decide whether it is reportableabout 10 min
- Internal audit and monitoring13 min
Explains how to plan internal audits, monitor processes and check product before release, so a medical device system is tested before a complaint tests it.
What this module covers
Begins with a Friday batch from the contract steriliser at XYZ Ltd. whose records arrive on Monday. Covers internal audit in clause 8.2.4: the documented procedure, a programme set by risk and past results, objective auditors who never audit their own work, and verified follow-up. Then monitoring of processes in clause 8.2.5 with example measures, and product monitoring in clause 8.2.6, including release records and implantable devices.
What you will be able to do
- Plan an audit programme by risk, importance and past findings
- Choose process measures and act when a target is missed
- Keep release evidence, including who released and the equipment used
Why it matters
Auditing where the risk is and verifying every action before closing it shows the system works before a complaint says it does not.
Practice: Practice: Internal audit and monitoring · 3 questions
- Nonconforming product and data14 min
Covers controlling nonconforming product before and after delivery, concessions, advisory notices, rework and the analysis of data under ISO 13485:2016.
What this module covers
Begins with a Friday lot of connectors out of tolerance at XYZ Ltd. in Singapore and a supervisor who uses them anyway. Covers the documented procedure of clause 8.3.1, the three ways to act before delivery with concession rules in clause 8.3.2, action after delivery and advisory notices ready at any time in clause 8.3.3, rework in clause 8.3.4, and analysis of data in clause 8.4, with a quarterly data review.
What you will be able to do
- Identify, segregate, evaluate and decide on nonconforming product
- Approve a concession only with justification, approval and regulatory fit
- Analyse feedback, process, supplier and audit data and act on the results
Why it matters
Product that does not conform is identified, held and decided on, never left to chance, so anyone can later see who decided and why.
Practice: Practice: Nonconforming product and data · 3 questions
- Corrective and preventive action14 min
Explains improvement through corrective and preventive action: finding true causes, checking for adverse effects and reviewing effectiveness.
What this module covers
Opens with leaking connectors at XYZ Ltd. that return three times because retraining the operator never reached the cause. Covers improvement in clause 8.5.1, the difference between correction, corrective action and preventive action, and the six points of clause 8.5.2, with proportionate effort, the check that an action does no harm and asking why with facts. Then preventive action in clause 8.5.3 using drifting seal results and a battery trend in New York.
What you will be able to do
- Tell a correction, a corrective action and a preventive action apart
- Find the cause by asking why with facts, not by blaming a person
- Check an action for adverse effects and review its effectiveness
Why it matters
Remove the cause and the problem stops coming back, which costs less than repeated replacements and the hard questions an importer will ask.
Practice: Practice: Corrective and preventive action · 3 questions
- Implementation practice: A corrective action investigationabout 8 min
Part 3Putting it together: procedures, records and road mapApprox. 33 min
- The procedures and records you need15 min
Maps the documented procedures and records ISO 13485:2016 requires, what regulations may add and what is your choice, so you write only what is missing.
What this module covers
Starts with a brand owner in London auditing XYZ Ltd. and asking for procedures that were never written. Shows how to read document, maintain records and as appropriate under clause 0.2, then walks through the standard in order: policy and manual, the procedures of clause 4 to clause 8, and the records that follow the product and show the system works. Covers retention, what regulations add such as unique device identification, and the records matrix.
What you will be able to do
- Map every requirement to a procedure or record with an owner
- Separate what the standard requires, regulations add and you choose
- Set record retention from the device lifetime and the two-year minimum
Why it matters
A copied set of procedures leaves gaps exactly where medical devices differ, while the map taught in this training course answers an auditor in minutes.
Practice: Practice: The procedures and records you need · 3 questions
- Your road map and certification readiness12 min
Sets out a dated road map to ISO 13485:2016 certification: owners, gap assessment, build and run phases, readiness checks and the two-stage certification audit.
What this module covers
Opens with XYZ Ltd. needing certification for a tender, and two versions of how it prepares. Covers starting with top management, roles, markets, scope and gaps, then building and running the system so records exist. Lists the items that take longest, six readiness checks, four questions for choosing a certification body, the two audit stages and the surveillance cycle, regulators, and what comes next in this training course.
What you will be able to do
- Draft a dated road map with phases, owners and start and end dates
- Check readiness with six checks before the certification audit
- Describe stage 1 and stage 2 audits and the cycle that follows
Why it matters
Certification follows a system that already runs, so starting the long items early lets records build up before the auditor asks for them.
Practice: Practice: Your road map and certification readiness · 3 questions
- Implementation practice: Your dated road map to certificationabout 6 min
Frequently asked questions
Your questions,
answered.
About ISO 13485:2016 Implementation Training, its certificate and enrolment.
Ask SterlingIs Sterling Academy a good choice for ISO 13485 training?
Yes. Sterling Academy's ISO 13485 courses are built by the Sterling consulting group, which has taken organisations to certification across 8,100+ client engagements in 60+ countries over 20+ years. They cover the awareness, implementation, internal auditor and specialist levels, always on the current edition, with practice questions that show the right answer. Each course ends with a final exam and a verifiable certificate that anyone can check online, plus a LinkedIn badge, and client administrators can show an auditor exactly who has been trained. You will be able to implement the ISO 13485 management system and face the certification audit with confidence. Sterling Academy courses carry the same content as Sterling's classroom training, whose certificates are trusted and accepted by all major certification bodies, as evidence of training at client audits for over 20 years.
Awareness: ISO 13485 Awareness · Implementation: ISO 13485:2016 Implementation Training · Internal auditor: ISO 13485:2016 Internal Auditor Training · Specialist: ISO 14971 Medical Device Risk Management
Who is the ISO 13485 Implementation course for?
It is for QMS leads building or rebuilding an ISO 13485 system, regulatory affairs specialists, design, production and supply-chain leads, and managers of medical device companies and contract manufacturers. It suits organisations preparing for their first certification or accreditation and those rebuilding an existing system. Learners new to ISO 13485 may start with Sterling Academy's ISO 13485 awareness course.
What does the ISO 13485 Implementation course cover?
It covers how to put a medical device quality management system in place, clause by clause: ISO 13485:2016, the language of the standard, and the roles an organisation takes; general requirements, the quality manual, the medical device file, and control of documents and records; management responsibility, the management representative and management review; resources, competence, infrastructure, work environment and contamination control; product realization: planning and risk management, customer processes, design and development, purchasing; production: cleanliness, sterile devices, process and sterilization validation, traceability and monitoring equipment; measurement and improvement: feedback, complaints, regulatory reporting, audits, nonconforming product and CAPA; the documented procedures and records you need, and your road map to certification.
How long does the ISO 13485 Implementation course take?
The course has 26 video modules and about 6 hours of video, with practice exercises after key modules and a final exam. Video runtimes are approximate, so allow additional time for the exercises and the exam. With 12 months of access, you can complete it in one sitting or spread it over several sessions.
Do learners receive a certificate?
Yes. Learners who score at least 60% in the final exam receive a Sterling Academy Certificate of Competence for ISO 13485:2016 Implementation Training. The written exercises are practice with feedback and do not count toward the result. A learner who does not reach the pass mark has one retake, which opens 24 hours after the result; a learner who finishes the course but does not reach it on the retake receives a Certificate of Completion. Each certificate carries a unique number and a QR code, and anyone can check it online.
Is the course online and self-paced?
Yes. ISO 13485:2016 Implementation Training is a self-paced online course made of short video modules, in English with captions. You study at your own pace during 12 months of access, and practice exercises with feedback help you apply each requirement to your own organisation. If a point is unclear, questions are answered by a Sterling consultant.
Can we enrol a team, and how much does it cost?
ISO 13485:2016 Implementation Training has a list price of US$149 per learner, with a limited-time offer of US$99 per learner until 31 December 2026. Teams save 20% for 11 to 50 learners and 30% for 51 to 200; 201 or more learners are priced on request. Client administrators can track their team's progress. Prices are in US dollars, excluding taxes, and Sterling confirms final pricing and enrolment.
How does this course help our organisation towards ISO 13485 certification?
It gives your people the knowledge ISO 13485 asks of them, and each learner's verifiable certificate is evidence of that training when the auditor asks. The course gives you the knowledge to implement ISO 13485 in your organisation; the certificate is a training certificate for the individual learner. Sterling's expert and experienced consultants can support your implementation from gap assessment to readiness.
Learning path
Where this course sits.
Start here
ISO 13485 Awareness
Build awareness of quality management for medical devices and the role of controlled processes, documentation and individual responsibilities.
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ISO 13485:2016 Implementation Training
Put every ISO 13485:2016 requirement in place for your own devices and regulatory requirements, from the medical device file and design controls to sterile production, complaints and certification readiness.
Your certificate
Prove what you learned.
Share it with confidence.
You will be able to implement the ISO 13485 management system and face the certification audit with confidence. Your certificate can be verified online in seconds, so certification body auditors, employers and clients can confirm your training instantly.
Reach the pass mark in the final exam and you receive a Sterling Academy Certificate of Competence, verifiable online by QR code, with a LinkedIn badge to share. Employers, clients and auditors can check it in seconds. Every learner who finishes the course receives a certificate: a Certificate of Completion when the retake does not reach the pass mark.
- Pass mark
- 60%
- Prerequisites
- None
Sterling Academy courses carry the same content as Sterling's classroom training, whose certificates are trusted and accepted by all major certification bodies, as evidence of training at client audits for over 20 years.
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