Tagigo
medical devices
About
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 - ...
Keywords
medical equipment manufacturing
medical devices
hospital & health care
Company Information
-
Employees 1
