TÜV Rheinland
Testing and Certification Services for Medical Devices Industry
TÜV Rheinland operates worldwide with its own laboratories, experts and auditors located in close proximity to customers and their businesses.
Founded since 1872, TÜV Rheinland stands for safety, quality and efficiency between man, technology and the environment and we are present on all continents, with locations in over 500 Cities in 69 countries.
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Meet our team at 2W25, Hall F, Basement 2
Our Expertise for the Safety of Your Medical Devices
EU Medical Device Regulation MDR 2017/745
We offer support for all manufacturers who are looking for a professional and reliable Notified Body to address the challenges by MDR and IVDR.
On your path to compliance we can advise, inform and ultimately carry out any necessary technical documentation review and auditing. We are backed by a global network of industry experienced specialists and facilities and offer a one-stop shop of medical device-related services.
More information about MDR services, click here
Medical Device Single Audit Program (MDSAP)
Established by the International Medical Device Regulators Forum (IMDRF), MDSAP is a global auditing and monitoring tool for the continual assessment of compliance of medical device manufacturing and products.
TÜV Rheinland is one of the few integrated service providers designated as Notified Body for both MDR and IVDR, accredited as Certification Body and recognized as MDSAP Auditing Organization (AO) – truly a single source provider.
The MDSAP audit fulfills the requirements of the following regulatory authorities:
- Therapeutic Goods Administration of Australia (TGA)
- Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA)
- Health Canada (HC)
- Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency (HMLW & PMDA)
- U.S. Food and Drug Administration (FDA)
More information about MDSAP services, click here
Safe and secure medical devices with recognized cyber security testing
MDR 2017/745, EU Medical Device Regulation, explicitly addresses cybersecurity requirements. In addition, the MDCG (Medical Device Coordination Group), which is composed of representatives from EU member states, has issued a guidance document focusing on cyber security.
We provide you the expertise you need to identify and understand the cyber security issues facing your device based on its design and purpose. Our comprehensive services aimed at ensuring your medical devices the best possible cyber security against hacks and other cyber-crime are broken into these areas:
- Penetration test
- Fuzz test
- Vulnerability scanning
- Application source code review
More information about Cybersecurity services, click here
Testing Services for Medical Devices
We support you with comprehensive services for testing your products from a single source. Our portfolio also includes other products used in the medical field, such as walkers, scooter mobiles, medical beds and patient lifts, medical lamps and luminaires, products with different light intensities and spectral light distribution, and personal eye protection.
- EMC
- Batteries
- Wireless
- Chemical Testing
- Other (partial) tests: Mechanical testing, environmental simulation, usability and ergonomics testing, and more.
More information about our testing services, click here
Services brochure download
About TÜV Rheinland
TÜV Rheinland stands for safety and quality in virtually all areas of business and life. Founded in 1872, with more than 150 years' experience, we are one of the world’s leading testing service providers. TÜV Rheinland’s highly qualified experts test technical systems and products around the world, support innovations in technology and business, train people in numerous professions and certify management systems according to international standards. In doing so, the independent experts generate trust in products as well as processes across global value-adding chains and the flow of commodities. Since 2006, TÜV Rheinland has been a member of the United Nations Global Compact to promote sustainability and combat corruption.
To learn more about us, please visit our website: www.tuv.com
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