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.

Vigilance Reporting

Our team scours all relevant global databases to uncover potentially relevant events.

  • Reporting from Weekly -> Annually
  • Global Multi-Country Adverse Event Search
  • Key AE Reviewed + Highlighted
  • Tending Data + Benefit Risk Update

Periodic Safety Update Report (PSUR)

Customize our EU MDR Compliant Template,  or Get a Full PSUR Drafted

  • Vigilance Reports
  • Systematic Safety Literature Review
  • All Future Document Updates Handled
  • Full MDR Compliance Guarantee

Post Market Clinical Follow-Up

Lean on our team’s experience getting PMCF Plans and Reports Approved.

  • MDR Compliant PMCF Plan
  • PMCF Strategy Expertise

  • Incorporation of Internal Complaint Data

  • Systematic Literature Review

What are you waiting for? Check out our process and complete PMS whitepaper today.

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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.

Medical Device Vigilance
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.

Ready to See More?

We aren’t here to waste your time.   So how about we show you the goods, and find out if we’re a fit for your device.

SEE OUR PROCESS