Preparation of Technical Documentation
The thorough preparation of Technical Documentation is essential to demonstrate the conformity of a medical device with the requirements of Regulation (EU) 2017/745 (MDR) or Regulation (EU) 2017/746 (IVDR).
We support manufacturers, authorised representatives, and other relevant entities in structuring, developing, and reviewing the technical documentation, ensuring full compliance with the standards set by European regulations and notified bodies.
Our services include
Complete Development
Complete development of Technical Documentation, including:
-General description of the product;
-Clinical evaluation;
-Risk management;
-Manufacturing information and quality control;
-Labelling and Instructions for Use (IFU);
-Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) data;
Review and Validation
Review and validation of existing documentation, with gap analysis
Assistance
Assistance with the preparation of complementary documentation
-Declaration of conformity;
-Certificates;
-Clinical plans and reports;
-Manufacturing records.
