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Freyr Solutions
4 在

Freyr Appointed as a UK Responsible Person for a French Device Manufacturer

Learn how Freyr helped a France-based medical devices company specialized in design,
manufacture and marketing of device products.
https://www.ukrpservices.com/

UK Responsible Person Services for Medical Device Manufacturers

Freyr provides UK Responsible Person (UKRP) services to foreign medical device manufacturers for product registration and market entry in the UK.
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Freyr Solutions
4 在

UK MHRA mandates Medical Device manufacturers located outside the United Kingdom (UK) and without any local business offices for MHRA UK Responsible Person registration. Manufactureres need to appoint a United Kingdom Responsible Person (UKRP) or UK Representative on their behalf, as a pre-requisite for device registration and launch of the device in the United Kingdom.

https://www.ukrpservices.com/a....-step-by-step-guide-

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Freyr Solutions
4 在

https://www.freyrsolutions.com..../medical-devices/reg
Our medical device Regulatory consulting services are tailored to guide you through the complexities of medical device Regulatory requirements. Right from the initial concept up to market entry, we will provide you with comprehensive support, ensuring your device's compliance with the regulations and standards.

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Freyr Solutions
4 在

The United States (US) medical device market is regulated by the US Food and Drug Administration (FDA), and manufacturers are required to navigate the registration pathways based on device risk classification to place their devices on the market. Freyr's expertise encompasses Regulatory intelligence and strategy, product classification, identification of US FDA's registration pathways (510(k)/De-NOVO/PMA/IDE), and more.

https://www.freyrsolutions.com..../medical-devices/med

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Freyr Solutions
4 在

As a trusted medical device Regulatory consulting firm, for nearly a decade, Freyr has been setting the industry standards in assisting Medical Device and IVD companies worldwide for end-to-end Regulatory needs and device registration.

https://www.freyrsolutions.com/medical-devices

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         Email: freyrcorp@freyrsolutions.com
  • 位于 USA
  • https://www.freyrsolutions.com/medical-devices
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Freyr, as a proven Regulatory partner, provides end-to-end Medical Device Regulatory services that span across decoding Medical Device classification, compiling Device documentation, Medical Writing, Device Registration and acting as an in-country representative. We customize the process with respect to service and software assistance for end-to-end device approvals. With our presence across the continents, Freyr offers Regulatory services for market entry and Regulatory compliance across all regions. Our dedicated team consist of a mixed pool of expertise offering one-stop solution for all the Regulatory needs.

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