| About US: |
DEKRA Certification is a world-class Notified Body, with offices in the US, The Netherlands, Germany, Switzerland, Israel and Japan. We offer full-service, “one-stop-shopping” for CE marking of medical devices, certification of Quality Management Systems (including CMDCAS), and Notified Body transfers. Special consideration given to startup/early stage medical device companies working with advanced technologies. We provide Regulatory Strategy Review and Clinical Protocol Review services in order to avoid unexpected ‘surprises’ (delays) during the certification process. Our in-house product experts are experienced in cardiovascular, neurovascular, minimal invasive surgery, active implantables, IVD’s, drug/device combinations and devices with animal tissue components.
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