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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

Over the Air (OTA) Testing
Over the Air (OTA) Testing  

OTA (Over the Air) testing ensures wireless device performance and overall device system performance.

Zigbee Testing and Certification
Zigbee Testing and Certification 

We test and certify products for automated smart systems supported by Zigbee technology.

Medical Device Single Audit Program (MDSAP)
Medical Device Single Audit Program (MDSAP) 

A reduction in audits means less business disruption.

ISO 14001 Certification
ISO 14001 

Get your environmental management system certified according to ISO 14001.

Electromagnetic Compatibility (EMC)
Electromagnetic Compatibility (EMC) Testing 

From medical products to wireless devices and beyond, our EMC testing services keep you compliant.

Sigfox Testing and Certification Services
Sigfox Testing and Certification Services 

We conduct testing and Sigfox Ready™ certification of devices for use on the Sigfox network.

Active und Non-Active Medical Devices
Active and Non-Active Medical Devices 

Active and Non-Active Medical Devices.

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

Certify your Quality Management System (QMS) for medical devices

Wi-Fi Testing and Certification
Wi-Fi Testing and Certification 

We provide Wi-Fi testing and certification for wireless products sold around the world.

RED Directive: Telecommunication Products
Telecommunication Products - Compliance with RED Directive  

Conformity Evaluation for Radio Installations and Telecommunications Products.

Bluetooth® Qualification Services
Bluetooth® Qualification Services 

We provide qualification services for Bluetooth® compatible devices to ensure quality products operate safely and reliably.

Tested Medical Device
Non-Active Medical Device Testing 

Increase your competitive edge and certify your non-active medical device products.

Green Product Mark
Environmental Label Green Product Mark 

Clearly label sustainable products with TÜV Rheinland’s Green Product Mark.

Specific Absorption Rate (SAR) Testing
Specific Absorption Rate (SAR) Testing 

Specific Absorption Rate (SAR) testing ensures the safety of wireless devices for human use.

Approvals for Greater China
Approvals for Greater China 

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

WEEE/RoHS Services
WEEE/RoHS Services  

Get Your Electronics Products Compliant with Waste Directives.

RoHS Compliance Testing
RoHS 

We test electrical and electronic devices according to the international standards applicable to your products.

Energy Efficiency and Saving Energy
Energy Efficiency and Saving Energy 

Improved Climate Protection with Energy-Saving Products.

CB Procedure
CB Certificate 

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

Smart Grid Product Testing
Smart Grid Product Testing  

Ensure Your Products Work in the Smart Grid.

cTUVus Certification
cTUVus Certification from an Accredited NRTL 

A step ahead of the rest – with cTUVus certification for the North American market.

Artificial Intelligence for Products
Artificial Intelligence for Products 

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

Usability and Ergonomics
Usability and Ergonomics 

A Real Plus for Your Customers: Functionality and Ergonomics.

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