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2021 - Fundamentals of EU MDR and IVDR – Level 1
Date2021-06-24 - 2021-06-25
Deadline2021-06-14
VenueVirtual Seminar, USA - United States 
KeywordsMedical Device Regulation; MDR; GSPR Annex 1
Topics/Call fo Papers
Objectives of the medical device regulation
Directives replaced with regulation
Risk based device classification
Conformity assessment and its relevant changes (Annex IX, Annex X, Annex XI)
Requirements for technical documentation found in GSPR Annex 1
UDI and traceability requirements, responsibilities, and impacts (EUDAMED)
Process for clinical evaluations
Clinical evidence with supported documentation
Post market requirements (Annex XIV and Annex 3 Part B)
Audit management and Notified Bodies requirements for manufacturers, as well as internal audit impact (Article 51, Annex V111)
Impact on the Quality Management System
Directives replaced with regulation
Risk based device classification
Conformity assessment and its relevant changes (Annex IX, Annex X, Annex XI)
Requirements for technical documentation found in GSPR Annex 1
UDI and traceability requirements, responsibilities, and impacts (EUDAMED)
Process for clinical evaluations
Clinical evidence with supported documentation
Post market requirements (Annex XIV and Annex 3 Part B)
Audit management and Notified Bodies requirements for manufacturers, as well as internal audit impact (Article 51, Annex V111)
Impact on the Quality Management System
Other CFPs
- Lifecycle Management of Analytical Methods and Procedures according to new USP and ICH Guidelines
- Designing and Sustaining New and Existing Product Stability Testing Program
- Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)
- Quality and GMP Compliance for Virtual Companies (Pharmaceutical and Biologics Industries)
- FDA's Medical Device Software Regulation Strategy
Last modified: 2021-05-17 04:26:50