A Complete Solution to EU MDR Post Market Surveillance
Done for you. Or With You. Our team has the expertise to handle all your PMS reporting for MDR, and the tools to empower your own team.
Industry Leading Timelines. Approval Guaranteed.
The Only Post Market Surveillance Decision You Need to Make
Post Market Surveillance under MDR has become a pain. Believe us, we understand. With multiple documents to juggle, different submission intervals, and (*cough*) ambiguity in the regs, it’s hard to stay organized.
Our team has built the experience, tools and processes to handle it all, year after year. All you have to do let us use them.
EU MDR Submission Expertise – Approval Guaranteed
We’ve been in the audit trenches, and aside from a scar or two have lived to submit another day. If we’re handling your submissions, you can rest assured that we’re operating on a breadth of collective experience.
Worry-Free Report Updates
Anyone can submit a plan for PMS, or PMCF. Very few can meticulously maintain records, run precise update searches/reviews, and keep your docs in compliance year after year. You approve the protocol, we take care of the rest. Forever.
Industry Leading Tools
Your data is too precious and complex to be managed through Excel sheets renamed ‘old’ as a means for version control. Without a system, it’s impossible to maintain a single device document, let alone hundreds of device documents.
That’s why we’ve invested years, and our children’s college funds (just kidding) in building State of the Art tools to keep your Adverse Events, Scientific Literature, and Documents managed.
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