Hogan Lovells Publications | 08 June 2020

We can help you prepare remotely for your next Quality Management System inspection or audit

The global spread of COVID-19 has resulted in the imposition of quarantine orders and travel restrictions that are affecting the ability of the U.S. Food and Drug Administration (FDA), notified bodies, and MDSAP Auditing Organization to perform on-site audits.

Further, limitations on personnel and staffing are creating challenges to completing scheduled internal audits or preparing for preapproval or postmarket surveillance inspections. Companies need to evaluate alternative ways to perform internal audits; not only to satisfy the annual audit requirements, but to also ensure that your Quality Management System is ready for the next inspection or audit; whether it happens virtually or in person.

Hogan Lovells can help. Our Medical Device and Technology Compliance Team has received ISO 13485 auditor certification and has developed a plan for conducting remote Quality System Audits of most elements of your Quality Management System. Our team has depth and experience in the issues that are unique to medical device manufacturers and has seen and evaluated hundreds of quality systems. Because of this experience, we are able to exercise the type of judgment that comes with experience and help you improve and protect your quality system.

Click here to learn more about our QMS eAudits and remote inspections capabilities.

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