BROAD RANGING KNOWLEDGE + EXPERIENCE

Our consultants have extensive first-hand knowledge and experience of medical device and In Vitro Diagnostic (IVD) regulatory requirements, gained from working within the industry and interfacing with regulatory authorities.

COMPANION DIAGNOSTICS

COMPANION DIAGNOSTICS

Our Companion Diagnostics expertise extends across FDA Q-Subs, Japanese PMDA BD preparation, PMA submissions, clinical site set-up, protocol development, global clinical site monitoring and more...

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IN VITRO DIAGNOSTICS

IN VITRO DIAGNOSTICS

ARC Regulatory has a specific focus on in vitro diagnostic medical device consultancy, with a significant proportion of our clients being leaders in the IVD medical device industry...

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GENERAL MEDICAL DEVICES

GENERAL MEDICAL DEVICES

Our medical device expertise spans non-active surgical equipment, through to complex medical software-driven electro-mechanical systems, across all risk classifications and regulatory paradigms...

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