Recognising the need for a tailored, personable and strategic approach to medical device consultancy, ARC Regulatory was established in 2009 by Seamus Kearney, with the primary goal of easing the journey towards regulatory compliance for companies in the Medical Device and In Vitro Diagnostic Medical Device industry.

Our sector areas include:

In Vitro Diagnostics
Companion Diagnostics
General Medical Devices

Now providing expertise in all areas of regulatory, clinical and quality assurance for general medical devices, in vitro diagnostic medical devices and IVD companion diagnostics, ARC supports clients at every stage of the product life-cycle, from feasibility and pre-market development, through approval to post market surveillance, vigilance reporting and clinical follow-up.

Our services include all areas of:

Regulatory Affairs
Clinical Affairs
Clinical Research Support
Risk Management
Usability Engineering
Medical Device Software

We work with medical device organisations of all sizes, from start-ups to “top 10” multi-nationals, and our integrated, professional and collaborative approach has been developed to deliver gold-standard solutions in our clients’ organisations.

Just starting out?

For early stage companies, we can help you define the most appropriate strategic plan to successfully launch a high-quality, safe and effective new product, or to enter new global markets.

Established organisations

For the more established companies, our experience can complement in-house expertise to assist with specific project or compliance activities. We also provide training for senior personnel, and execute internal audits of your cGMP and/or ISO 13485 quality system.

ARC Regulatory are active members of MedTech Europe & BIVDA, and participate in ISO Technical Committees 212 & 210 for medical device standards development.

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