What We Do

UK Responsible Person
UK RESPONSIBLE PERSON
UKCA MARK CONSULTANTS
UKCA MARK CONSULTANTS
EUDAMED REGISTRATION
EUDAMED REGISTRATION
POST MARKET SURVEILLANCE
US FDA CERTIFICATE
US FDA CERTIFICATE
US FDA 510K
The implications of Brexit on the medical device industry are significant. With the UK officially leaving the EU on January 31, 2020, there are anticipated changes in the trade of medical devices and in vitro research. Over 20,000 UK manufacturers, along with a substantial number of others, are aiming to obtain UKCA accreditation in the forthcoming years. Both regions are actively engaged in meeting the requirements of the Medical Device Regulation (MDR), which involves updating technical documentation and reassessing clinical trials for devices. As a leading regulatory authority in the UK for medical devices, we offer comprehensive assistance to companies seeking timely approval, registration, and specialized domestic services.
The introduction of the new regulations MDR 2017/745 for medical devices and IVDR 2017/746 for in vitro diagnostic devices has brought about significant compliance challenges for both established and emerging companies. Cert 3 Global offers legal assistance to companies aiming to swiftly achieve compliance with reduced in-house resources.
We provide comprehensive regulatory consulting services for medical devices, assisting with registration, 510(k) guidance, and serving as a US agent for all types of devices. Our service guarantee ensures successful outcomes, and our pricing structure remains consistent throughout.

63

REGULATORY EXPERTS

+1k

SUCCESSFUL PROJECT

07

YEAR OF EXPERIENCE

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