Press Release (ePRNews.com) - GARDNER, Mass. - Jul 16, 2017 - A.P.LYON offers a solution for medical device companies engaged in the design and development of medical devices to help them comply with FDA and ISO 13485 requirements.
The medical device Design Control Procedures Bundle includes multiple ISO 13485 and FDA QSR compliant quality system procedures related to the design and development of medical devices. Each procedure is written in accordance with ISO 13485 and FDA QSR requirements. The procedures are offered in a digital format and are available for instant download.
The Design Control Procedure Bundle includes the following individual procedures:
Design Control Procedure
Design Review Procedure
Design Change Procedure
Design Transfer Procedure
Product Performance Specification Procedure
Design Verification and Validation
Unique Device Identification (UDI) Procedure
The A.P. Lyon procedures comply with the FDA QSR and 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.
A. P. LYON