Our FDA Medical Device and Technology compliance team receives ISO 13485 auditor certification

Our team of compliance lawyers and regulatory science professionals has over 100 years combined experience working with medical device companies. To complement our extensive real-world, practical experience, our team of compliance lawyers has received ISO 13485 auditor certification and enhanced Medical Device Single Audit Program (MDSAP) training. We understand how the international standard and U.S. Quality System regulations interact, and we can help you plan and manage for the interplay of the two because we know you only operate one quality management system (QMS).

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