Medical Devices (Dir. 93/42/EC) and In Vitro Diagnostic Diagnostics in vitro (Dir. 98/79/EC) EC MARKING

US Market registration (FDA, 510(k), PMA)

Canadian Market registration

Personalized Vigilance

Clinical Evaluation

Regulatory expertise

Quality

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REACH Registration, Evaluation, Authorisation and Restriction of Chemical substances.

 

Harmonized standards

 

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European Directives 93/42 & 98/79

Adverse side effects Vigilance

French, European, American and Canadian Regulations

EUDAMED Registrations

Clinical Investigations

European directive 2005/50/EC

Table of equivalence between 21CFR Part 820 and ISO 13485 (2003)

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