Tagigo

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
• ...