ISO 13485 Awareness

It is for employees, supervisors and managers in medical device design, manufacture, supply and service, including manufacturers, importers, distributors, contract manufacturers, sterilisers and component suppliers. A suggested staff path of six modules suits production, warehouse and service staff; management, quality, regulatory, design and purchasing staff take the full course.

It covers why a medical device quality management system matters; documentation and the medical device file; management responsibility; competence, infrastructure and work environment; risk management across the product life cycle; design and development, purchasing, production, validation and traceability; feedback, complaints, nonconforming product and corrective and preventive action; and internal audit and management review.

The course is planned as 15 video modules and about 120 minutes of video, with practice questions after each module and a 30-question final exam: about 2 hours 40 minutes in all. A suggested staff path of six modules takes about 48 minutes of video. With 12 months of access, learners go at their own pace.

Yes. Learners who reach the 70% pass mark in the final exam receive a Sterling Academy Certificate of Completion for ISO 13485 Awareness. Each certificate carries a unique number and a QR code, and anyone can check it online using the certificate number and the holder's surname. It is a training certificate for the individual learner.

Yes. ISO 13485 Awareness 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 questions after modules help you check your understanding before the final exam. If a point is unclear, questions are answered by a Sterling consultant.

ISO 13485 Awareness is US$19 per learner. Teams save 20% for 11 to 50 learners and 30% for 51 to 200 learners; 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.

No. The Certificate of Completion is a training certificate: it shows that one person completed ISO 13485 Awareness and reached the pass mark in its final exam. It is not certification of an organisation to ISO 13485, and Sterling does not certify organisations. An organisation is certified by an independent certification body after that body's own audit.

ISO 13485 sets out a quality management system for regulatory purposes, and it supports an organisation in meeting regulatory requirements across the product life cycle. How a regulator uses ISO 13485, and how devices are classified, is decided by the regulator in each market. The course explains why device class matters without teaching any one regulator's rules.