Medical Writing Services for IVDR Compliance

 
INDUSTRY
Medical Device
SERVICES
Medical Writing
SKILLS
PEP
SVR
APR
PER
CPR
Full team of Medical Writers provided within 48 hours.
The Challenge

Our client was looking to move all of their legacy products to In Vitro Diagnostic Regulation (IVDR). However, all internal resources were currently allocated to operational projects, so additional resources would be needed to compile and complete the required clinical reports for IVDR certification. In addition, this client would need a fast turnaround, with only 48 hours’ notice of kickoff.

The Solution

We collaborated with the client to determine their requirements and, as a result, brought on ten consultants to support them. Over the course of two years, we supported the client with:

  • Two Medical Writers who performed a literature search within a two-week timeline.
  • One Medical Writer to cover all instruments and Class A products. This individual provided Scientific Validation Reports (SVRs), fixed costs, and a Performance Evaluation Plan (PEP) for each product.
  • Five Clinical Science Leads who managed vendors, provided medical writing support, and reviewed and managed literature searches, SVRs, PEPs, and Performance Evaluation Reports (PERs).
  • Three Medical Writers to cover higher-risk products, including Class C companion diagnostics.
The Result

We provided engagement management support, wherein we regularly met with the Client and Medical Writers to manage deliverables, timelines, and invoicing. The Medical Writers often supported multiple reports across several products in parallel, which required additional detail for the client reports. We were able to kick off with a full team of Medical Writers within 48 hours. These individuals completed PEPs, SVRs, APRs, Clinical Performance Reports (CPRs), and PERs for multiple products. We continue to support this client with additional PEPs, SVRs, and PERs for the necessary products. With the established working relationships and institutional knowledge we developed, scheduling deliverables and estimating work efforts came easily. We continue to support the client on various IVDR reports.