ARC Regulatory is a medical device consultancy and Clinical Research Organisation that specialises in the delivery of compliant solutions to complex regulatory issues for companies in the medical device and in vitro diagnostic medical device industries. Our sector areas include: In Vitro Diagnostics, Companion Diagnostics and General Medical Devices.
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 industries. Now providing expertise in all areas of regulatory, clinical and quality assurance, 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
- Quality Management
- Clinical Research Support
- Risk Management
- Usability Engineering and
- Medical Device Software
We work with medical device organisations of all sizes, from start-ups to top 10 multi-nationals:
- 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
- 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.
We take an integrated and collaborative approach to deliver commercially-focused compliance solutions for our clients.
ARC Regulatory are active members of MedTech Europe & BIVDA, and participate in ISO Technical Committees 212 & 210 for medical device standards development.