Meditec Source acchieved official MDR Certification

 

Meditec Source achieves Certification in Compliance with Annex IX, Chapter I & III of Regulation (EU) 2017/745.


We are thrilled to announce that Meditec Source has successfully achieved certification under Annex IX, Chapter I & III of Regulation (EU) 2017/745 on medical devices. This significant milestone underscores our unwavering commitment to quality, safety, and regulatory excellence in the medical device industry.


This certification officially covers the following classifications of medical devices:


Class I
Class Ir (Reusable surgical instruments)
Class Im (Measuring function)
Class IIa


By achieving this certification, Meditec Source reaffirms its dedication to delivering safe and effective medical devices that meet stringent European Union standards. We extend our gratitude to our team and partners for their hard work and support in this accomplishment.


This milestone strengthens our position as a trusted provider in the healthcare industry and empowers us to continue advancing medical innovation for better patient care.

 

 

 

 

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Our employee responsible for Regulatory Affairs, Mrs. Dr.-Ing. Ulrike Hess obtained the Doctorate Degree end of 2017.

Dr.-Ing. Ulrike Hess

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