Articles for Medical Device Manufacturers

These articles explain how to navigate the medical device approval processes in particular in Europe ("CE-Marking") and the US (FDA). 

The topics

The articles are grouped into the following categories:

1. Regulatory Affairs: Here you find articles introducing the regulatory frameworks and describing the medical device approval processes.
2. Quality Management and ISO 13485: In most cases quality management systems are a pre-requisite for placing medical devices in the European or US market. Learn the steps how to establish, audit and improve quality management systems.
3. Product Development: Developing medical devices is much more than complying with regulations. Articles provide insides into system architecture, definition of intended use, clinical evaluation, verification and validation and much more.
4. Usability Engineering & IEC 62366: The usability or human factors engineering becomes increasingly important. Learn with these articles not only the regulatory with respect to usability engineering, but also the methods to derive requirements, to specify user interfaces and to verify and validation the usability with formative and summative evaluations.
5. Risk Management & ISO 14971: The most important requirement for medical device manufacturers is to develop and to market medical devices that are safe, that provide the promised benefits and that have risks which are acceptable when weighted against the benefit. The articles in this section explain how to determine the risk benefit ration, how to analyze and mitigate risks and how to comply with ISO 14971.

Assistance

More help needed? The team of the Johner Institute helps you and your company to develop and market medical devices fast and without unnecessary hassle. If you have any question, our experts will help. 

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About the authors

The articles are written by Johner Institute's experts:

• ISO 13485-Lead-Auditors
• Members of standard committees such as IEC 62366 and IEC 62304
• Experts for regulatory affairs, software development, usability engineering, risk management
• Trainers of European notified bodies
• Consultants
• Physicians, physicists, computers scientists, electrical engineers etc