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 CFDA 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