Press Release (ePRNews.com) - GARDNER, Mass. - Jul 18, 2017 - A.P.LYON offers a solution for medical device companies engaged in the manufacture and global distribution of medical devices to ensure compliance with FDA, MDR EU 2017/745 and ISO 13485 requirements governing the process of complaint handling, reporting and any required corrective action.
The Medical Device Complaint Handling Procedures bundle includes multiple ISO 13485 and FDA QSR compliant quality system procedures, including forms and reporting decision tress, that cover the entire complaint handling process. Each procedure is written in accordance with FDA, MDR EU 2017/745 and ISO 13485:2016 requirements. The procedures are offered in a digital format and are available for instant download.
The Complaint Handling Procedure Bundle includes the following individual procedures:
Complaint Handling Procedure
Complaint Trending Procedure
Remedial action – Recall Procedure
Medical Device Report (MDR) Procedure
Vigilance Report Procedure
The A.P. Lyon complaint handling procedures comply with FDA CFR’s, 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.
http://www.aplyon.com/store/p67/Complaint_Handling_Proced… Source :
A. P. LYON
Business Info : A. P. Lyon