Our latest white paper on Literature Monitoring Challenges and Opportunities is out. Get it here!
Medical Devices Vigilance (Materiovigilance)
biologit
Vigilance Regulations for Medical Devices
The medical device environment is rapidly growing and becoming increasingly regulated. Global requirements for safety surveillance and materiovigilance include the EU MDR 2017/745, EU IVDR 2017/746, FDA CDRH regulations, and other global regulations. In particular, the clinical evaluation report (CER) and other regulatory submissions require supporting literature reviews to achieve compliance.
Your Partner in Medical Device Vigilance
As your global partner, our experts can assist medical device companies of all sizes with your literature monitoring needs from project setup and training to ongoing literature surveillance of regulatory submissions including:
Clinical Evaluation Reports (CER)
Port-Market Surveillance Reports (PMSR)
Post-Market Clinical Follow up (PMCF)
Periodic Safety Update Reports (PSUR)
biologit was shortlisted as a top innovative SME at MedTech rising: Ireland's flagship medical devices summit, December 2023 (learn more)
Literature Monitoring for Medical Device Vigilance (Materiovigilance)
Monitoring the scientific literature for adverse events is a critical component of active materiovigilance and regulatory submissions for medical devices.
​
The biologit's MLM-AI platform is a validated and compliant SaaS solution for medical device companies, with a flexible workflow, built-in scientific literature database and unique AI productivity to help ensure your products are compliant and audit ready.