Risk Management Procedures Simplify ISO 13485, ISO 14971 and FDA Compliance

GARDNER, Mass. - July 16, 2017 - PRLog -- 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 solutions.


Email:***@aplyon.com Email Verified
Tags:ISO 14971, Risk Management, Iso 13485, Medical Device, Procedure, Design Risk, Production Risk, Design Analysis
Industry:Industrial, Manufacturing, Medical
Location:Gardner - Massachusetts - United States
Account Email Address Verified     Account Phone Number Verified     Disclaimer     Report Abuse
Page Updated Last on: Jul 17, 2017

Like PRLog?
Click to Share