European Medical Device useful links:

  1. Links to European Harmonized Standards
  2. Medical Device Directive -93/42/EEC- (MDD)
  3. In Vitro Medical Device Directive -98/79/EEC- (IVDD)
  4. Active Implants Medical Device Directive -90/385/EEC- (AIMD)

Other useful European Union Links:

    1. European Commission
    2. Eucomed (European Confederation of Medical Devices Associations )
    3. Heads of Regulatory Agencies in the EU
    4. European Information System Medical Devices (EUDAMED)

Other useful Links Outside of Europe:

  1. Health Canada Website
  2. FDA Homepage
  3. NF Mark

Interesting blogs:

  1. Medicaldeviceslegal.com

FAQ

  1. Q&A Risk Management
  2. FAQ Software Development Lifecycle – IEC 62304