ARC REGULATORY

ARC Regulatory is a medical device consultancy and Clinical Research Organisation that specialises in the delivery of regulatory compliance solutions for companies in the in vitro diagnostic and general medical device industries. Founded in Northern Ireland in 2009 by Seamus Kearney, our primary goal is to ease the journey towards regulatory compliance for every organisation that we work with. ARC Regulatory supports clients at every stage of the product life-cycle, from feasibility and pre-ma... rket 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 have worked with medical device organisations of all sizes throughout Europe and beyond, from start-ups to top 10 multi-nationals: - For early stage companies, we help define the most appropriate strategic plan to successfully launch a high-quality, safe and effective new product; and to enter into new global markets - Working with larger companies, our experience complements in-house expertise, assisting 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 ensure we 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. Visit www.arc-regulatory.co.uk to find out more, tel. +44(0) 28 7963 9304 or email [email protected]More