Give Us 3 Minutes and Avoid Your Next Product Launch Derailing!
You probably did a great job of making sure your products were compliant with the stringent new MDR requirements in Europe. But if your component suppliers haven’t fully met all of the MDR’s UDI label, software documentation and risk analysis circulation requirements, you will lose time and money. Steute is fully MDR-ready to supply you the necessary documentation and certifications you’ll need to launch your new products successfully and on time. Call us today and see why Steute is always right on track with the right wired and wireless foot control products at the right time.
Transcript
00:00:04 [Music] [Music] [Music] similar to the u.s the regulations for medical products are now being harmonized across europe as of may 2021 medical products can only be classified and approved according to the new medical device regulation anyone wishing to do business in europe
00:01:17 will have to fulfill these stricter requirements but what does all this have to do with deuter as your partner for safe and innovative hand and foot controls we do more we manage most of the testing and documentation for you at streeter this service is always included we provide added value in regulatory
00:01:43 matters since 1998 stoid has been producing medical foot controls as certified components for medical devices always according to the latest quality standards we have now extended this to include the american market thanks to our establishment registration we can link up to your medical system
00:02:04 [Music] in 2019 we elevated the documentation process for our user interfaces in europe this includes complete conformity documentation for all our products from fulfillment of year requirement specification to risk management including all the software our product documentation ultimately
00:02:26 simplifies approval of your overall system you will also receive all the necessary documentation regarding our production processes not only do we have a wealth of experience and expertise as a manufacturer of innovative user interfaces [Music] but we also provide added value in
00:02:48 regulatory matters everything you need for smooth and easy approval of your overall system [Music] interested we look forward to talking to you you