Your IVDR Performance Evaluation
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PERs written for you, or with you
All come with Guaranteed approval

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A PER Process

That Fits Your Team

Work With Us On Your Terms

Have some great writing staff already? Or limited budget? Plug directly into our process and use our expertise only when you need it.

Full PERs End to End

Our team of Notified Body Acceptable PER writers can deliver a complete document
ready for submission.

Use Our Templates

Draft your new MDR PER from our templates. Complete training annotations, and Notified Body insights included.

100% Success Rate

How We Do It:

We are one of the only writing teams out there confident enough to guarantee our work.  But before you roll your eyes and mutter “Nothing’s guaranteed in Regulatory Affairs”… hear us out.

We only work with great products and even better teams:  If your device or submission is headed for disaster because of unrealistic claims fraudulent clinical data,  or if your team is full of jerks… we won’t be able to help.

You get support through the entire audit:  We don’t just zip up a pile of documentation and send you on your way.  All of our projects include free consulting hours to address Auditor feedback, and ensure your get through successfully.

See our track record for yourself: We have extensive lists of reference.  Drop us a line and we’d be glad to put you in touch with clients who saw success using our team/methods.

 

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Delivered On Your Timeline

By the time they start, We have already finished.

Our process slashes your timelines, budgets and boosts PER writing productivity.
All while delivering a product that is more consistent, thorough, and higher quality than the competition.

Clinical Evaluation

An Audit Pro On Your Side

Notified Body Audits are tough to navigate on your own.  Benefit from our teams countless submission successes and experience in drafting precise responses for all rounds of your Audit.

Dedicated Writing Team

Not all medical writers are created equal… which is why we hang on to our team of experience writing leads for dear life!

Our writing team is experienced, with cumulative 100s of successful documents authored and submissions navigated for clients.

Our writing team is qualified, all writers meet the Notified Body and EU Standards for a Clinical Reviewer/Author

Our writing team is diverse, dotting the globe geographically, and in terms of international regulatory requirements, you won’t find a more robust team.

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IVDR Compliance challenges

Transition Strategy

With less time to transition from IVDD to IVDR, a proven method is required. To begin, sort through the confusion and select the appropriate Notified Body. Gather all of the evidence.

Product Portfolio Prioritization

Examine and evaluate each of your devices based on their role in the company’s overall product portfolio. Consider the rising clinical and regulatory costs.

Several Modifications to Documentation & Labelling

The IVDR (Annexes II and III) gives a list of content required as part of technical documentation for each product. Because of the intricacies of the IVDR supply chain, each distributor is designated as a “economic operator,” with regulatory and legal responsibilities.

Interpretation of Requirements

The overarching goal of all of these adjustments is to develop a “quality management system.” If you want to do business in the EU, you must comply with EN ISO 13485:2016.

Peace of Mind For Your Submission

Our team is built and trained to get your PER approved.   Whether you need a complete service, or are just looking for some occasional doc review and literature support the CiteMed team is ready to jump in.

IVDR compliant PERs
Classes I, IIa, IIb & III
Specialists in SaMD
Guaranteed Approval
Free audit support hours for your entire submission
5 week delivery available

Calgary Scientific "It definitely met my return on investment expectations." Chris Slaymaker Chris Slaymaker General Manager, Healthcare Hunter Healthcare "We weren't just looking for someone afforable, but also able to give us a quality product. Otherwise we wouldn't have kept working with CiteMedical." Haleema Ahmed International Regulatory Affairs Specialist Venus Concept "You actually get more than what you pay for." Sylvia Wilkinson Sylvia Wilkinson Director, Regulatory Affairs and Quality Assurance Circa Scientific "It allowed us to keep within our budget for regulatory expenses, without having to stop selling in Europe, basically!" Quality Assurance Manager Channel Medsystem "[CiteMed] was very responsive and adherent to the timeline we had all agreed upon. It was excellent!" Director, Clinical and Regulatory Affairs Calgary Scientific "We suggested the cadence for meetings and that was kept up throughout the project and we had additional calls at very short notice, when we need to." Chris Slaymaker Chris Slaymaker General Manager, Healthcare Circa Scientific "The deliverables captured the whole requirements of the EU MDR regulations." Quality Assurance Manager Venus Concept "CiteMed is very fun! They're very self starting, self efficient...CiteMed could take it and run with it!" Sylvia Wilkinson Sylvia Wilkinson Director, Regulatory Affairs and Quality Assurance Channel Medsystem "By the time Citemed had already provided me with the SOW/quote, I was still sorting through NDAs and initial intake calls with other companies. The timeliness and urgency with which you were able to get started was the critical factor for me because we were on a really short timeline." Director, Clinical and Regulatory Affairs Calgary Scientific "I felt that the pricing was fair for the amount of work involved." Chris Slaymaker Chris Slaymaker General Manager, Healthcare Venus Concept "The timelines and level of service I got from CiteMed exceeded all expectations." Sylvia Wilkinson Sylvia Wilkinson Director, Regulatory Affairs and Quality Assurance

IVD services provided by Citemedical

Gap Assessments

  • Device Classification as per IVDR (Classes A, B, C, D)
  • Technical Documentation
  • QMS development and implementation

Global Registrations

  • UDI and Labelling Requirements
  • Technical File Creation
  • Submission and Review
  • CE-Marking and International

Medical Writing

  • Performance Evaluation Plan (PEP)
  • Performance Evaluation Report (PER)
  • Scientific Validity Report (SVR)
  • Analytical Performance Report (APR)
  • Clinical Performance Report (CPR)
  • Post-Market Performance Follow-Up Plan (PMPF)


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Start Today – See Our PER and Get a Quote

View the intricate details of our writing process, our experience and qualifications, and our unheard of guarantee.

Are You Ready to Work With Us?

If You Are…

Short on staff and resources to write and maintain Performance Evaluation Reports and Systematic Literature Reviews.
Perfectionists that want a consistent system and operating procedure to keep your PER compliant with IVDR year after year.
In need of a single centralized platform to securly store your scientific literature, review and trending data over time (for easy updates and audits)

We might be a fit!

Medical Device Vigilance
Notifed Body Approved Writers

Our writers have the chops to tackle any classification of device for IVDR, and the CVs to submit alongside your final document. Our team has cumulatively written well into the 100s of PERs on all device classifications.

Consistent Updates If You Need Them

Keep your Literature Review, and PER documents updated year after year without worry or hassle.  We keep everything organized and audit ready.

Post Market and Vigilance Data Support

If you have a team and process in place for PMS, great! If you don’t, our comprehensive PMS packages are easily integrated into your submission.

Get Ahead of Your Timeline.  Start Today