Freelance consultancy supporting (start-up) companies in digital health / medical device sector to navigate the complex regulatory landscape for their software products. - Regulatory support including strategy definition - Support in EU MDR/IVDR and FDA technical documentation planning, compilation, submission, audit follow-up - Product development life cycle process design and optimisation - Support in project management & product management - Support in implementation of ISO 13485, ISO 14971, IEC 62304, IEC 82304-1, etc. - QMS internal audit for ISO 13485, EU MDR, EU IVDR - ...
| Employees | View employees |
| Industry | Medical Equipment Manufacturing |
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