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 articles are grouped into the following categories:
- Regulatory Affairs: Introduction to the regulatory frameworks and descriptions to the medical device approval processes.
- Quality Management and ISO 13485: Learn the steps on how to establish, audit and improve quality management systems. In most cases quality management systems are a pre-requisite for placing medical devices in the European or US market.
- Product Development: Obtain insight onto the system architecture, definition of intended use, clinical evaluation, verification and validation and much more. Developing medical devices is much more than complying with regulations.
- Usability Engineering & IEC 62366: : Learn not only engineering usability and requirements, but also the methods to specify user interfaces and to verify and validate the usability with formative and summative evaluations. The usability and human factors of engineering become increasingly important.
- 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. Understand how to determine the risk benefit ratio, how to analyze and mitigate risks and how to comply with ISO 14971.
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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
- Physicians, physicists, computers scientists, electrical engineers etc