In vitro Diagnostics Directive (IVDR)
All in vitro diagnostic devices sold in the European Union need to have a CE marking.
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Medical Device Services
We are active almost everywhere in the world and the members of our medical device team have extensi
Medical Device Services
We are active almost everywhere in the world and the members of our medical device team have extensi
Medical Device Services
We are active almost everywhere in the world and the members of our medical device team have extensi
Medical Device Services
We are active almost everywhere in the world and the members of our medical device team have extensi
Medical Device Services
It is essential that your Notified Body has the capabilities and expertise to support you with robust product certification and system certification reviews to ensure patient and user safety. We are active almost everywhere in the world and the members of our medical device team have extensive expertise in a wide array of medical and in vitro devices.
In addition to being a designated European Notified Body, we are also a recognized MDSAP auditing organization. We offer all the essential services to manufacturers of medical devices: AIMDD, MDD, IVDD and MDSAP.
ISO 13485
ISO 13485 helps you to meet the requirements that apply to your Quality Management System (QMS).
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Medical Device Regulation(MDR)
The MDR will replace the current Medical Device Directive (93/42/EEC) (MDD) and Active Implantable Medical Devices Directive (90/385/EEC) (AIMDD) on 26 May 2020.
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Medical Device Single Audit Program (MDSAP)
The Medical Device Single Audit Program (MDSAP) is designed to allow a single audit for medical device manufacturers that is accepted in multiple regulatory jurisdictions.
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UKCA Marking for Medical Devices
DEKRA Is Now an UK Approved Body
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