Showing results for: medical device regulations services
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STEMart - Notified Body (EU) Services
CE marking is the manufacturer's declaration that their product complies technically and administratively with the essential regulatory requirements of Medical Device Directive 93/42/EEC (MDD) and its supplementary Directive 2007/47/EEC, Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) and In ...
By STEMart based in Shirley, CALIFORNIA (USA). from Medical Device Development Service - Medical Device Certification Services Service line
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Quality Management Services
KARL STORZ has put in place a certified quality management system in accordance with the standards DIN EN ISO 9001:2015 and DIN EN ISO 13485:2016. In addition, the system meets the requirements of the European Medical Devices Directive 93/42/EEC Annex II and additional national regulations and legal ...
By Karl Storz SE & Co. KG based in Tuttlingen, GERMANY.
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Quality Services
management system fulfills the requirements of the European Medical Devices Directive 93/42/EEC Annex II on medical devices as well as other national and legal guidelines and standards, such as QSR of the US FDA. In doing so, we want to ensure that the manufactured products meet a level that our customers around the world ...
By GEOMED Medizin-Technik GmbH & Co. KG based in Tuttlingen, GERMANY.
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Active and Non-Active Medical Devices
When it comes to medical devices, quality and safety are especially vital. As a notified body, we can help you with your conformity assessment procedure and ensure that your active and non-active medical devices comply with EU Directive 93/42/EEC. Tap into the European ...
By TÜV Rheinland AG based in Köln, GERMANY.
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