Search

Clarification of the Term "Legal Entity" for MDSAP Recognition Purposes

Medical Devices: Post-Market Surveillance -IMDRF National Competent Authority Report (NCAR) Pilot Plan

Medical Devices: Post Market Surveillance: National Competent Authority Report (NCAR) Pilot Plan; Implementing Material

Strategic Assessment of Electronic Submission Messaging Formats

Statement regarding Use of ISO 14971:2007 "Medical devices - Application of risk management to medical devices"

Statement regarding Use of IEC 62304:2006 "Medical device software - Software life cycle processes"

Statement regarding Use of IEC 60601-1 "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance"

Statement regarding Use of ISO 10993-1:2009 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"

Statement regarding Use of ISO 11137-1:2006 "Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices"

IMDRF Table of Contents (ToC) Pilot Plan