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Services for Active Implantable Medical Devices


TÜV Rheinland

Current medical technology is capable of delivering healing solutions via active implantable medical devices (AIMD). These products work inside the patient’s body to calibrate and regulate physical functions, improve quality of life and extend life spans. Because they are designed to essentially become part of an individual’s body, AIMDs are subject to special scrutiny regarding safety, functionality and durability. As a manufacturer of implantable medical devices, it is your priority to stand up to this scrutiny and even exceed expectations when possible. With experts by your side with specialized knowledge of this technologically sophisticated field, your chances for success rise substantially. Our services for AIMDs address your goals and concerns, enabling you to consistently demonstrate compliance and build a strong record for safety and reliability in your sector

Medical Device Safety and Testing at a Glance

Medical Device Regulation (MDR) 2017/745

Start here. - Check the newest regulations, certificate transition dates, and common FAQs for in vitro diagnostic and medical device requirements. Are you prepared for EU, US and key market approval?

New Regulations for Medical Products

pdf New IVDR 1 MB Download
pdf MDR / IVDR declaration of interest 92 KB Download
pdf Regulation (EU) 2017/745 1 MB Download
pdf Regulation (EU) 2020/561 522 KB Download

Our portfolio

Artificial Intelligence for Products
Artificial Intelligence for Products 

A guide for understanding the impacts of the EU AI ACT on Products

EN ISO 13485 Certification
EN ISO 13485 certification of QMS for medical devices | TÜV Rheinland  

Certify your Quality Management System (QMS) for medical devices

Approvals for Greater China
Approvals for Greater China 

We provide comprehensive approval and certification services for fast entry to Greater China market.

CB Procedure
CB Certificate 

CB certification as a globally recognized method for testing the safety of electrical devices.

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