Design Control for Medical Devices (ENG) (2 day)


This is a 2 day course focused on how to develop new medical devices and maintain them in organisations where design control requirements apply. The course covers both European and US requirements.

The course addresses documentation requirements and provides tools on how to work successfully and efficiently with Design Control. It references the most commonly used standards such as ISO 14971 on risk management and IEC 62366 on usability engineering.

We recommend this course for professionals involved in the development of medical devices such as quality assurance, project management, design engineering or those involved in R&D and product development teams.

All of this course is included in our Project Management for product development of medical devices course.

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