ECA - GMP for Medical Devices

Art-No.: A-997
Date: 06-07 November 2018

Price: EUR 380,-

The Conference folder includes the following topics:

No. Topic Summary Pages
12603European Regulatory Requirements Under Consideration of the New European MDR037
12604Differences between European and US Requirement01
12605Certification Procedures/ Technical Documentation Under Consideration of the New European MDR049
12606Combination Products037
12607Device History File/Device Master Record029
12609Design Controls053
12610Qualification and Validation054
12611Regulatory Audits035
12612CAPA/Complaint Handling044
14059Overview about similarities/differences between Medicinal Products and Medical Devices048
14060Classification and Premarket Submission of Medical Devices in the USA023

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