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Medical devices - we are your preventive measure when it comes to safety.

We have something for your medical devices: a healthy level of safety. To ensure that you as an engineer or product manager can rely on valid results, we offer you comprehensive services from our experts.

It goes without saying that we are familiar with the Medical Devices Directive and its harmonized standards and always have our finger on the pulse. As is the fact that our trainers know their profession inside out thanks to their own professional experience.

You can rely on us from the accredited SGS-TÜV Saar and thus on experts who, together with your engineers, developers or QM officers, will lay the foundations today for the developments of tomorrow and your certification.

Do you have questions about medical devices?

Medical devices: We know our way around here

You know it yourself: The medical device market is diverse and regulation is complex.

Let us talk to you personally about the possibilities for support from SGS-TÜV Saar.

We offer workshops and support to clarify standards requirements. If specific product and process developments require the involvement of a cooperation partner due to accreditation requirements in order to provide a comprehensive service, we deliver solutions within the framework of our international SGS and partner network.

We test and audit concepts, products or processes.

Medical device testing: Here you even gain your expertise on paper.

If you, as an engineer or developer, decide to have your concepts, processes and products tested by our experts from SGS-TÜV Saar, one thing is certain: your concepts, processes and products are in good hands with our experts and in our laboratories.

You can rely on effective conformity testing and thus on sound specialist knowledge of the Medical Devices Directive and its harmonized standards. Place your trust in us at SGS-TÜV Saar as an accredited company in accordance with ISO/IEC 17025 and ISO/IEC 17020. And in the event that questions arise about your product, e.g. regarding electrical safety, we are happy to add further experts to our team. You can see for yourself: Our tests leave nothing to be desired in terms of knowledge.

Our standards:

  • MDR
  • IEC 60601-1 3rd Edition
  • IEC 60601-1-6
  • IEC 62304
  • IEC 62366-1
  • IEC 82304-1
  • IEC 61508

How to strengthen your brand: product with certificate in the medical sector.

Hardly anything can create more trust among users than a certificate that proves the quality of your product. We at SGS-TÜV Saar are therefore not only your reliable partner for testing. As an accredited service provider, we are also happy to provide you with certificates for concepts, products or processes in the medical sector following successful testing.

Strengthen your customers' confidence in your product. With us, the SGS-TÜV Saar.

 

This is how we ensure a healthy level of security:

Development-accompanying assessment

Instant access to updated standards

Maximum agility thanks to strong and experienced teams

Interdisciplinary cooperation for optimum testing depth

Product protection through legally sound expert opinions

Excellent quality through international assessor qualification

We look forward to your inquiry

Send us a message
Functional Safety (Munich)

SGS-TÜV Saar GmbH
Benzstr. 28
D-82178 Puchheim near Munich

t: +49 89 787475 271

 

 

 

Functional Safety (Dortmund)

SGS-TÜV Saar GmbH
Joseph-von-Fraunhofer-Str. 13
D-44227 Dortmund

t: +49 231 9742 7300