Products Aim to Streamline Compliance with New Medical Device Regulation (MDR) EU 2017/745, ISO 13485:2016 and FDA QSR

Incorporating risk management throughout all aspects of medical device manufacture and commercialization is a common theme in the recent changes to various standards and regulations. The risk management system that A.P. Lyon has incorporated into their system products is aligned with and reflected in the clinical evaluation process for a medical device, including the clinical risks to be addressed as part of clinical investigations and clinical evaluation and post-market clinical follow up. The risk management procedures instruction on device characterization, risk assessment, risk-benefit analysis and all risk related activities.

New Unique Device Identification (UDI) requirements have been incorporated into both U.S. and European regulations. In order to help companies address the new global requirements associated with the traceability of devices by means of a UDI system, a procedure based on international guidance was created to help manufacturers adhere to the new requirements and provide instruction on both formatting UDI's and for data entry into FDA GUDID and EUDAMED systems.

A.P. Lyon's quality system procedures aim to help manufacturers continue to meet their previous critical obligations that were made part of the MDD and FDA CFR's, such as clinical evaluation reports (CER), medical device reports or vigilance reporting and the post-market surveillance and the risk management process.