Medical Device Quality and Regulatory Consulting
MD Compliance offers quality systems compliance consulting for medical device manufacturers. We work across the UK, EU and North America from our base in Glasgow, bringing a range of expertise and experience gleaned from working for a variety of medical device manufacturing companies, from start-ups and SMEs to global companies. Below, we have listed some useful resources and links relevant to our clients. If you'd like to find out more about what we offer, call us today on +44 (0)7973 403 486 .
Europe
EU Regulation 2017/745 (EU MDR)
EU Regulation 2017/746 (EU IVDR)
List of EU MDR Notified Bodies
List of EU IVDR Notified Bodies
List of EU Competent Authorities and other Contacts
EU Harmonised Standards (EU MDR)
EU Harmonised Standards (EU IVDR)
Medical Device Coordination Group (MDCG) Guidance Documents
USA & Canada
FDA Device Advice
FDA Quality System Regulation
21 CFR Part 820 (QSR) - regularly updated electronic version
Canadian Medical Devices Regulations
SOR/98-282