With you, preparing, completing, collating and maintaining your Technical Documentation.
Designing a defined, efficient structure, for documentation for your Product, Group or Family to meet specific country requirements and embrace as appropriate:
EC Medical Device & IVD Regulation Annexes I, II and III Requirements
Device History File (DHF)
Device Master Record (DMR)
Risk Management File
Declarations / Statements of Conformity
Post Market Surveillance Plan
Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)
In accordance with your Regulatory Strategy, and specific Country requirements we identify, collate, prepare and submit the documentation necessary to successfully achieve the CE / CA Mark, Regulatory Clearance, Listing or Licensing as appropriate.