Medical device manufacturers must audit their quality systems on a regular basis to ensure compliance with the appropriate regulations and standards. Failure to do so can result in poor product quality, loss of certification, or lack of process improvement. Medical device companies often ask us to conduct Quality Management System compliance audits and/or audits of their system to ensure compliance with the FDA Quality System Regulation (FDA QSR – 21 CFR Part 820), ISO 13485:2016, Japan Ministerial Ordinance 169, Korea GMP, Brazilian GMP, and Canadian Medical Device Regulations (CMDR). We typically perform medical device QMS audits for companies because they do not have the resources or expertise to conduct them, or they prefer having an independent company do internal audits to ensure unbiased results.
Interested in upgrading to ISO 13485:2016? See how we can help.
Emergo by UL can provide eQMS support in strategic alliance with Greenlight Guru. This helps you leverage an eQMS system designed specifically for the medical device industry. Ask us to schedule a demo so you can explore a software solution that connects with your processes, people, and data.
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Within the UL family of companies we provide a broad portfolio of offerings to all the Medical Device industries. This includes certification, notified body and consultancy services In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our Brand and our customers brands UL is unable to provide consultancy services to Notified Body or MDSAP customers. UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality. Read more about this.