NBN - Handbook ISO 13485:2016

The guidance given in this handbook describes concepts and methods that can be considered by your organization to assist in the development, implementation and maintenance of your QMS and this can be applicable to the design, development, production, installation, servicing and post market surveillance of medical devices.This handbook has taken into consideration requirements and guidance contained in documents as listed in the bibliography from the following organizations:• International Medical Device Regulators Forum (IMDRF) including thosedocuments maintained from the disbanded Global Harmonization TaskForce (GHTF);• International Organization for Standardization (ISO);• European Committees for Standardization (CEN and CENELEC);• National regulatory bodies.