ECA - GMP for Medical Devices

Art-No.: A-997
Date: 01-02 October 2019

Price: EUR 380,-

The Conference folder includes the following topics:

No. Topic Summary Pages
12603GMP-related Requirements of EN ISO 13485-2016037
12604Differences between European and US Requirement01
12605Certification Procedures under the European MDR049
12606Combination Products037
12607Device History File/Device Master Record030
12609Design Controls053
12610Qualification and Validation054
12611Regulatory Audits under MDR and MDSAP035
12612CAPA/Complaint Handling045
14059Overview about similarities/differences between Medicinal Products and Medical Devices040
14060Classification and Premarket Submission of Medical Devices in the USA024

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