Skip to content

Institute for Medical Device Compliance & Regulations

Archive for:

Category: News

MDR 2020

Impact of COVID-19 to Technology and delayed MDR

March 31, 2020March 31, 2020

AI Innovations in Primary Care Heartcare!

January 9, 2019March 26, 2019

Categories

Article
News

Recent Posts

Explained: Planning of product realization in ISO 13485:2016 (part 1)
Explained: Contamination Control by ISO 13485
Infrastructure requirements in ISO 13485
Work Environment as per ISO 13485
Human resources in ISO 13485

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.