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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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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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 regimes.

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