Conformity Assessment based on a Quality Management System and on assessment of Technical Documentation

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How ready are you for the Medical Devices Regulation (MDR)?
The MDR (EU) 2017/745 which replaces the MDD (93/42/EEC) and AIMDD (90/385/EEC) has a transition period of three years. Manufacturers have the duration of the transition period to update their technical documentation and processes to meet the new requirements.

The scope of the new MDR (EU) 2017/745 is significantly increased compared to the MDD (93/42/EEC).

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Questions about this topic and your device – Contact
Randi Hauerberg
Principal Advisor/Team Lead
Regulatory Affairs & Quality Management
Connect with me on LinkedIn

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