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Services for Medical Devices


TÜV Rheinland

Manufacturers of medical devices are held to an extremely high standard. Regulatory bodies, hospitals, health care practitioners and patients expect the devices used to treat and heal illnesses and injuries to be safe and to perform as promised. The stakes are high in this sector, and the level of technology unmatched. It takes teamwork to succeed in this market, to be competitive, to establish a reputation for reliability and to stay abreast of new scientific and regulatory developments. We are valuable team players with the skills, stamina and specialized services necessary to assist you in producing and operating the most effective, technologically sophisticated and safest products for the medical sector. Benefit from our comprehensive services, fast lead times and our long-standing experience in the field of medical devices.

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

Medical Devices

Team player for your medical products and in vitro diagnostics.

Active Implantable Medical Devices
Active Implantable Medical Devices  

Special scrutiny regarding safety, functionality and durability of active medical implants.

Active Medical Devices
Active Medical Devices  

Enabling compliance and high safety standards for active medical equipment.

Pharmaceutical Packing Materials
Pharmaceutical Packaging Materials  

Make sure your medical products are properly wrapped and boxed.

Non-Active Medical Devices
Non-Active Medical Devices  

A reliable partner for compliance, performance and safety of non-active medical equipment.

Regulations
Regulations  

We certify equipment for the medical industry in compliance with recognized international standards.

In-Vitro Diagnostics
In-Vitro Diagnostic Devices  

Ensuring the reliability and safety of your IVD medical devices.

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