Support for MDR Certification

As a medical device manufacturer, you have probably already managed to secure a contract with a Notified Body for the extended Medical Device Regulation (MDR) transition period! Now you face the next big challenge: preparing the technical documentation, one of the most complex and critical tasks.

Did you know that a Notified Body can find up to 50-100 non-conformities in an average technical documentation? Correcting non-conformities is a time-consuming and expensive process that delays certification and increases the cost of the entire project.

Our Services

Pre-audits

• MDR Technical Documentation pre-audit

• MDR / ISO 13485 Quality Management System pre-audit

Handling of non-conformities

• Correcting non-conformities or providing consultation for their correction

• Checking the corrections made by the client

MDR Technical Documentation preparation practice-oriented personalized trainings

• General Safety and Performance Requirements – GSPR checklist preparation and its relationship with other elements of the technical documentation (MDR I.)

• Risk Management File preparation and its relationship with other elements of the technical documentation (ISO 14971)

• Design and Development File preparation and its relationship with other elements of the technical documentation (ISO 13485)

• Software Development File preparation and its relationship with other elements of the technical documentation (IEC 62304, IEC 82304 1)

Preparation of all or any separate part of the MDR technical documentation

• Usability Engineering File, usability tests

• Biological Evaluation

• Clinical Evaluation

• Post-Market Surveillance (PMS) plan and report or Periodic Safety Update Repor

Full implementation of MDR / ISO 13485 quality management Trainings

• ISO 13485 Internal Auditor Training

• ISO 14971 Risk Management

• IEC 62366-1 Usability Engineering

• IEC 62304 Software Development