Complaint Handling Procedures Simplify FDA and EU Compliance

GARDNER, Mass. - July 18, 2017 - PRLog -- 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.


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