Medical Devices

Medical devices from the common disposable syringe to the complex radiation treatment machines are classified as high risk devices in the healthcare industry. Considerations in product quality, safety and efficiency are of paramount importance in the conceptualization of such devices.

TÜV SÜD, a Notified Body to a wide variety of Directives, can conduct legally prescribed tests and certifications for medical devices manufacturers globally and for all risk classifications.  TÜV SÜD PSB further provides expert opinions on safety and quality regulations, testing and certification according to international standards.

Our services

The medical devices testing and certification services include:

• Product testing and certification
• EC conformity procedures
• CB certification
• Laboratory tests for ergonomics, electrical, mechanical, functional safety, software and data security
• Doc Cert: test and certification of operating instructions
• Target-group-specific users tests to check the user-friendliness of products (e.g. in the field of rehabilitation)
• Electromagnetic compatibility tests
1. IEC 60601-1-2 (Ed.2)
2. IEC 61000-3-2/-3
3. IEC 61000-4-2/-3/-4/-5/-6/-8/-9/-10/-11/-12/-13
4. IEC 61000-6-1
5. IEC 61326
6. IEC 62543
7. IEC 62547
8. CISPR 11/12/13/14/15/20/22/24/25
• Biocompatibility evaluation of medical devices
• CB test laboratory
1. IEC 60601-1 (Ed.2 & Ed.3)
2. IEC 60601-2-10/-38
3. IEC 61010-1
4. IEC 61010-2-081
5. IEC 61131-2
• Certification for medical devices (National Certification Body)
1. IEC 60601-1
2. IEC 60601-2-3/-5/-10/-16/-18/-22/-16/-17/-30/-34/-37/-38

 

Your advantages:

Reduce your business risks by meeting regulatory requirements and standards. Increase quality and safety of your products and processes. Save time and costs as we provide you with a one-stop testing and certification service. Leverage on our global accreditations. Leverage on our state of the art laboratories with comprehensive testing equipment and professional expertise. Increase customer confidence in your product when your product goes through independent testing Shorten your time-to-market and increase market access when you meet regulatory requirements and standards.  Our team is highly experienced and qualified, which adds value to your processes.