Dekra Medical Devices

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Services for Medical Device Makers - DEKRA

https://www.dekra.us/en/medical-devices/

DEKRA operates in over 60 countries delivering a safer world through consulting, inspections, testing, certification, auditing, and training. DEKRA is a trusted partner for …

Medical Device Services | DEKRA

https://www.dekra.com/en/medical-device-services/

Globally recognized certification body: With a global network of offices and state-of-the-art laboratories, we provide services and certifications that are needed for a worldwide market access including Europe, Taiwan, the …

Medical Device Services - DEKRA North America

https://www.dekra.us/en/product-testing/medical-devices/overview/

Globally recognized certification body: With a global network of offices and state-of-the-art laboratories, we provide services and certifications that are needed for a worldwide …

Healthcare and Medical Device Industry | DEKRA

https://www.dekra.com/en/healthcare-and-medical-device-industry/

DEKRA conducts comprehensive testing, analysis, training and certification services designed to help healthcare facilities and medical devices manufacturers meet …

Medical Device Regulation (MDR) | DEKRA

https://www.dekra.com/en/medical-device-regulation/

DEKRA has two Notified Bodies for the EU Medical Device Regulation (2017/745, MDR): DEKRA Certification GmbH (NB 0124) and DEKRA Certification B.V. (NB 0344). With the combination of these Notified …

Medical Device Regulation - DEKRA North America

https://www.dekra.us/en/product-testing/medical-devices/medical-device-regulation-mdr/

DEKRA has two Notified Bodies for the EU Medical Device Regulation (2017/745, MDR): DEKRA Certification GmbH (NB 0124) and DEKRA Certification B.V. (NB 0344). With the …

Medical Device Regulatory Services | DEKRA PTC

https://www.dekra-product-safety.com/en/solutions/medical-device-services

Ensuring safe medical devices for global markets. As a medical device manufacturer, you must navigate your way through a complex landscape of regulatory requirements before …

Medical Device Single Audit (MDSAP) - DEKRA

https://www.dekra.us/en/product-testing/medical-devices/medical-device-single-audit-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. Led by …

Notified bodies | DEKRA

https://www.dekra.com/en/notified-bodies/

DEKRA Certification GmbH is a notified body and certification body for medical devices. As a Notified Body with the identification number 0124, DEKRA Certification GmbH …

UKCA Marking for Medical Devices - DEKRA

https://www.dekra.us/en/product-testing/medical-devices/ukca-medical-devices/

DEKRA has begun the process to become an approved body, and designation is expected in mid-2022. All medical devices placed on the market must be registered with the MHRA. This regulatory body has …

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