Medical Writing Services 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 consulting services include regulatory medical writing solutions for various reports like the CEP, CER, PEP, PER, APR, CPR, SVR, and PMS. Moreover, our experienced medical writing consultants offer valuable insights, guiding you through the complex Regulatory requirements with precision and expertise.

  • 25

    +

    Total Clients
  • 25

    +

    Ongoing Projects
  • 260

    +

    Product Expertise
  • 5

    +

    Partnered with leading Medical Device Companies
  • 95

    %

    On-time Submission
  • 4-5
    Business Weeks Ideal TAT*

Medical Writing Services for Medical Devices Overview

At the intersection of science and language, regulatory 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. That's why we aim to make your experience as effortless as possible. We provide unparalleled regulatory medical writing consulting 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, versatile range of professional medical writing services, team of expert medical writing consultants, 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.

Freyr’s Medical Writing Services

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 (SSP)
  • 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