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Regulatory

Nerac’s team of analysts provide regulatory support during and after market approval.

We guide and support new product development, continuously monitor safety and performance of products, and provide pre- and post-regulatory assistance.

Our medical device regulatory services include:

  • State of the Art Literature Review, for EU CERs, and to support other business needs (e.g., expanded indications, other FDA-related activities)
  • Clinical Literature Evaluations for EU and NMPA regulatory submissions, including Device Safety & Performance and State of the Art
  • EU Clinical Evaluation Reports (CERs) (in accordance with Regulation (EU) 2017/745, with process guided by MEDDEV 2.7/1, Rev. 4, June 2016)
  • CER Remediation and Audit Response
  • CEP/CER Template or Draft Gap Analysis
  • Vigilance Alerting/Period Literature Searches in support of Post-Market Surveillance Activities, as an input to risk management activities, and for ongoing preparation for CER updates

Our team specializes in medical device regulatory compliance, with a focus on clinical evidence from literature search and review. Our in-depth knowledge of European medical device regulations ensures that we can assist you in determining an efficient regulatory strategy for your device. Complying with the new MDR requirements may seem like a daunting task, particularly with a looming deadline, but Nerac can help you create the right documentation.

Other regulatory services include:

  • Clinical Literature Evaluations for EU regulatory submissions for in vitro diagnostics, per requirements of the European In Vitro Diagnostic Regulation (IVDR) [2012/0267 (COD); 22 Feb 2017]
  • State of the Art Literature Review for in vitro diagnostics, for EU submissions and other business needs
  • Regulatory Compliance (FDA) for Dietary Supplements
  • Regulatory Compliance for Food Packaging Materials

Contact us at +1 860 872 7000 to discuss how we can help you.

Clients say they use Nerac because…

"I've used NERAC during past employment and I've always found your literature search services to be among the best!"

"The level of expertise is unmatched and resources at their disposal are superb. I most often send them complex research questions."

"Keeps me up to date on available literature and patent info."

“We were heavily involved in developing pharmaceutical delivery devices and required quite a bit of Nerac support in the areas of patents and prior art. The services provided by Nerac were impressive and thorough.”

Regulatory Case Study

NGS Assays: Here are the Variables of Clinical Performance

Originally published Sept 8, 2023
By Sarah McLeod, M.S., Regulatory Analyst/Medical Writer

Next-generation sequencing (NGS) assays provide a clinically valid resource for precision medicine. Knowing how NGS assays perform on different regions of a chromosome with different genetic variants helps to determine the benefit of these tests for specific patient groups. This article offers a bulleted list of clinical performance evaluators by which to analyze published clinical trials. Get the article here.

Ultrasound: Expanding Commercial Horizons

Originally published August 18, 2023
By Richard Hendriks, Ph.D.

This article explores emerging technologies in the field of therapeutic ultrasound. Get the article here.

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