Medical Device Management & Consulting consulting@regpromedical.com +1 (425) 241 - 3092
RegPro Medical
We know WHAT to do. We do it RIGHT. The FIRST Time.
Technical File
Each country or market has its own unique requirements for technical documentation of the device design, manufacturing, quality assurance processes, verification and validation. And each country or market has its own specific expectations for the details to be included, areas of focus, and review process.
The EU Medical Device Regulation has specific requirements for Technical Documentation (often referred to as the “Technical File”). Detailed Notified Body review of the Technical Documentation is required for all devices except Class 1. The documentation must contain details of the device design, manufacturing, Risk Management, Quality Management System, verification, validation, and Clinical Evaluation, to name a few, and it needs to be meticulously organized to facilitate the thorough review that the Notified Body will conduct. The Notified Body typically has a series of questions and follow-ups during the review process.
What will RegPro Medical Do?
When you are ready to expand into new countries and markets worldwide, RegPro Medical will help you identify the specific requirements and expectations for technical documentation submissions and will give you the support you need to write, compile, and submit the documentation the right way and as efficiently as possible.
When you are ready to apply for CE Marking, RegPro Medical will author, organize, and tailor your technical documentation to get your marketing application done right the first time. We will also support you to provide complete and professional responses to Notified Body questions during the review process.