Webinar subjects include
The Medical Devices Regulation (MDR)
- MDR Article 18 Implant Card
- Update to the regulatory implications of Brexit (Sept 2018)
- What are the regulatory implications of Brexit? (May 2018)
- QMS aspects of the MDR (& IVDR)
- EU Harmonization – MDR Requirements & progress on key standards & labelling
- General Safety and Performance Requirements in the New MDR
- Technical Documentation requirements under MDR, including requirements for legacy files
- Roles and responsibilities in the Medical Device and IVD Regulations
The In Vitro Diagnostic Regulation (IVDR)
- Update to the regulatory implications of Brexit
- The regulatory implications of Brexit
- General Safety and Performance requirements of the IVDR
- Roles and Responsibilities in the MDR and IVDR
- QMS aspects of the MDR (& IVDR)
QMS, ISO 13485 and medical device standards
- QMS aspects of the MDR (& IVDR)
- EU Harmonization – MDR requirements & progress on key standards & labelling
- New versions of ISO 13485:2016 and ISO 9001:2015
- ISO 13485:2016 publication
The Medical Device Single Audit Program (MDSAP)
- Critical update on Medical Device Single Audit Program (MDSAP): Countdown for Canada
- Are you ready for the Medical Device Single Audit Program (MDSAP)?
Market access requirements
- Post Market Surveillance and Vigilance - do you know the requirements?
- Usability engineering, a new focus: Do you understand the requirements?
- Nanomaterials and Medical Device Regulations
- Validation and Verification, are you clear on the requirements?
- Electro-Medical Device Market Access: Frequently Asked Questions