Technical Document Support

We enhance the medical device and diagnostic documentation process through all-encompassing support services.

  • Data collation and organization for regulatory submissions and technical documentation/GSPR, including clinical and performance evaluation documents
  • Authoring technical documentation and GSPR in alignment with EU MDR and IVDR
  • Toxicologist support for biocompatibility risk assessments
  • Human-factor engineering support for usability studies
  • Information reviews related to the design, function, etc.
  • Review of dossier structures in alignment with global regulations
  • Clinical data review and authoring Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs)
  • Risk management files, product specifications, labels, and instructions for use
  • Support for review, development, and management of Performance Evaluation Plans (PEP) and Performance Evaluation Reports (PER) for analytical performance, clinical performance, and scientific validity to demonstrate the safety and performance of products
  • Responsible for the development, implementation, and maintenance of the quality management system

Document Gap Analysis

Our goal is to assess existing documentation against established criteria and standards, rectifying gaps to serve for pre-market submissions and post-market surveillance activities.

  • Device regulatory risk classification
  • Intended use
  • Artwork and labeling
  • Manufacturing information
  • Risk management files
  • Post-marketing surveillance
  • Verification and validation of the device
  • Quality management system setup and maintenance

Explore Real-World Evidence Solutions