QMS, ISO 13485, MDSAP and medical device standards
- Symbols to be used on labelling (ISO 15223) and information to be provided by the manufacturer (ISO 20417)
- ISO 14971:2019 Risk Management for Medical Devices
- Update to the regulatory implications of Brexit
- QMS aspects of the MDR (& IVDR)
- EU Harmonization – MDR requirements & progress on key standards & labelling
- Critical update on Medical Device Single Audit Program (MDSAP): Countdown for Canada
- Are you ready for the Medical Device Single Audit Program (MDSAP)?
- New versions of ISO 13485:2016 and ISO 9001:2015
- ISO 13485:2016 publication
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