Search results with tag "Medical device technical documentation"

MDS G5 Guidance on Requirements for Medical Device …

classification of the device. General 1 Medical device shall comply with the “Essential Principles of Safety and Performance” specified in Annex (1) and Annex (2). 2 Medical device manufacturer shall: − Prepare, hold and update the “Medical Device Technical Documentation” and/or “IVD Technical Documentation” that

  Devices, Medical, Technical, Documentation, Medical device, Technical documentation, Medical device technical documentation