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.

Comprehensive Reporting

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

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

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.

Our Clients Say

I’ve never seen such a streamlined process for literature search and review. CiteMed produced elegant reports that were easy to read despite their length and incredible detail

Quality Director, Medline Industries

Free Articles and Post Market Surveillance Whitepapers

  • Market Surveillance of Medical Devices Under the EU MDR

Market Surveillance of Medical Devices Under the EU MDR

November 8th, 2022|Comments Off on Market Surveillance of Medical Devices Under the EU MDR

The term market surveillance covers the activities carried out by national regulatory authorities to ensure the safety and efficiency of products placed on the market. In these activities, the national regulatory authorities put measures [...]

  • Post-Market Surveillance

The Post-Market Surveillance Document: Which Ones Do you Need?

November 1st, 2022|Comments Off on The Post-Market Surveillance Document: Which Ones Do you Need?

It's not enough to make a device and put it on the market—you must know how people use your product. Therefore, the post-market surveillance must cover all devices that have been placed on the market, [...]

  • Post-Market Surveillance

Post-Market Surveillance Process and What It Will Cost You

October 4th, 2022|Comments Off on Post-Market Surveillance Process and What It Will Cost You

Post-market surveillance and vigilance costs are overgrowing. For example, the number of reported adverse reactions has increased annually by approximately 10-15% over the past five years. In addition, costs for post-market surveillance have been growing, [...]

  • post-market surveillance, clinical performance

Post-Market Surveillance, Market Surveillance, and Vigilance – What is the Difference?

August 30th, 2022|Comments Off on Post-Market Surveillance, Market Surveillance, and Vigilance – What is the Difference?

Most regulatory staff can define post-market surveillance relatively succinctly. Perhaps also vigilance. But when it comes to market surveillance, what exactly makes it different from post-market surveillance? And why is vigilance a separate entity [...]

  • PMCF studies

Post-Market Clinical Follow-Up (PMCF) Studies for Medical Device Manufacturers

July 26th, 2022|Comments Off on Post-Market Clinical Follow-Up (PMCF) Studies for Medical Device Manufacturers

While post-market clinical follow-up (PMCF) played a part in the MDD (Directive 93/42/EEC), the updated Medical Device Regulation (MDR, 2017/745) introduced stricter rules for post-market surveillance, including post-market clinical follow-up. The increase in clinical data [...]

Worry-Free EU MDR Compliance

1. Searching and Data Ingress

CiteMed (Through Automation and Careful Human Auditing) Collects Adverse Event Data from all of your chosen global sources

2. Expert Review of All Search Results

Our team of medical writers reviews the results and classifies any relevant Events for you to be included in the next Vigilance Report. (this is optional).

3. All Results Made Visible on Your Dashboard

Search results as well as our team’s reviews/classifications are immediately available for you to access on your CiteMed Dashboard.

4. Vigilance Report Document Is Delivered

On your chosen time interval, CIteMed delivers an Adverse Event Report to you via email and accessible directly on your CiteMed Dashboard.

All Your Vigilance Data In One Place

If You Are:

Short on staff and resources to conduct multiple Vigilance reports every quarter.

Perfectionists that want a consistent system and operating procedure to satisfy Post Market Surveillance requirements.

In need of a single centralized platform to securly store your AE Reports and trending data over time.

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.