Skip to content

Institute for Medical Device Compliance & Regulations

Archive for:

Tag: MDR

MDR 2020

Impact of COVID-19 to Technology and delayed MDR

March 31, 2020March 31, 2020

How to get CE Mark

This is what you should know when applying for CE Mark

February 5, 2020February 5, 2020

Categories

Article
News

Recent Posts

Management Review Output in ISO 13485
Management Review Input in ISO 13485
Explained: Management review of ISO 13485
Importance of Internal communication in ISO 13485
Central Part of the ISO 13485 Quality System

Tags

#medicaldevice Article audit CAPA CAPA requirements CAPA steps Compliance DMS document control document management software employees eQMS FDA inspection ISO ISO 13485 iso13485 ISO14971 management review MDR MDR2020 medical device medical device file Medical devices outsourced manufacturer paper-based Processes Product QMS qms manager qms software qmsWrapper quality management system Quality Manager Quality Manual Quality Policy RCA Regulations requirements risk riskanalysis riskmanagement Root Cause Analysis Standard Traceability

© 2020 — Institute for Medical Device Compliance & Regulations, Designed by Evolve Themes and Proudly powered by WordPress.