Press Release (ePRNews.com) - GARDNER, Mass. - Jul 16, 2017 - A.P.LYON offers a solution for medical device companies engaged in the design, development and manufacture of medical devices to help them comply with FDA and ISO 13485 requirements.
The medical device Risk Management Procedures Bundle includes multiple ISO 13485 and FDA QSR compliant quality system procedures related to the risk management process for medical devices. Each procedure is written in accordance with ISO 14971, ISO 13485 and FDA QSR requirements. The procedures are offered in a digital format and are available for instant download.
The Risk Management Procedure Bundle includes the following individual procedures:
Product Risk Management Procedure
Design Risk Management Procedure
Production Risk Management Procedure
Design Analysis Techniques Procedure
The A.P. Lyon procedures comply with ISO 14971:2012, FDA QSR, ISO 13485:2016 and MDR (EU) 2017/745. A.P. Lyon has done the work and hopes companies around the world will take advantage of their soultions.
http://www.aplyon.com/store/p69/Risk_Management_Procedure… Source :
A. P. LYON