Medical Writing for Medical Devices

Clinical and performance evaluation forms a vital step in proving the safety, efficacy, and performance of medical devices and In Vitro Diagnostics (IVDs). Our services include Regulatory medical writing consulting for various reports like the CEP, CER, PEP, PER, APR, CPR, SVR, and PMS. Moreover, our experienced medical device consultants offer valuable insights, guiding you through the complex Regulatory requirements with precision and expertise.

For Regulatory Success, Contact Now!

Send us your details and we will get in touch.

Medical Writing for Medical Devices Overview

At the intersection of science and language, medical writing for medical devices plays a crucial role in translating complex medical concepts into accessible and understandable content. It bridges the gap between technical jargon and everyday language, ensuring that vital information reaches diverse audiences in a clear, concise, and accurate manner.

Freyr understands that navigating the vast realm of medical information can be overwhelming, which is why we aim to make your experience as effortless as possible and so we provide unparalleled regulatory medical writing services by leveraging a team of highly skilled and experienced professionals who blend scientific expertise with exceptional communication skills.

With a comprehensive understanding of regulatory guidelines, a versatile range of regulatory medical writing services, stringent quality assurance measures, and a proven track record of timely delivery, Freyr stands at the forefront of the industry, ensuring our clients receive the highest standard of service and achieve their medical writing objectives with utmost confidence.

Medical Writing for Medical Devices

  • Creation of Clinical Evaluation Plan/Report
  • Creation of Performance Evaluation Plan/Report
  • Clinical Performance Report (CPR)
  • Analytical Performance Report (APR)
  • Scientific Validity Report (SVR)
  • Summary of Safety & Performance Report (SSCP)
  • Lifecycle management of medical writing reports
  • Gap analysis of Previous CER, PER, and the related source documents
  • Post market Surveillance plan
  • Post Market Surveillance Report
  • Post Market Clinical Follow Up Plan (PMCF Plan)
  • Post Market Clinical Follow Up Report (PMCF report)
  • Periodic Safety Update Report
  • Assured compliance with recent applicable regulations.
  • Team of qualified experts.
  • Tailored Solutions to your requirements
  • Regulatory Resource Management/Staff Augmentation Services
  • Cross-functional inputs from Medical Device experts to comply with requirements.