ARC Regulatory

About Us

ARC is a Medical Device consultancy and Clinical Research Organisation that specialises in delivering compliance excellence for companies in the IVD, CDx and general medical device sectors.

Our mission is to deliver platinum-quality life-cycle support solutions for every one of our client organisations. ARC Regulatory supports companies at every stage of the product life-cycle, from technical and clinical feasibility, product development through approval to post market surveillance and clinical performance follow-up.

Our expertise includes:

Companion Diagnostics


Regulatory Strategy, Alignment & Submissions

Clinical Project Management, Protocol Development and Report Writing

Clinical Operations including site set up and Global Study Site Monitoring

Medical Device Clinical Quality Assurance

Biostatistics - Study design and Data Analysis

Quality Management

Usability & Risk Management

We work with medical device organisations throughout Europe and beyond, from start-ups to Top 10 multi-nationals. Here's how we tailor our service to suit customer needs:

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. 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 client cGMP quality systems.

We take an integrated and collaborative approach to ensure we deliver commercially-focused compliance solutions for all of our clients. ARC Regulatory are active members of MedTech Europe & BIVDA, and participate in ISO Technical Committees 212 & 210 for medical device standards development.

Useful Information

Introducing ARC Regulatory

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Space for Precision Medicine arrives in the Commission Proposal

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What is a CRO and why do you need one?

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Whitepaper - How to implement a CDx in to your drug development Programme

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Get a 360 view of global regulatory intelligence with ARC360

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ARC Inc.

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Our pivot to remote monitoring

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10 things to know about MDR Post Brexit

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1 The Cornstore, Market Street,
County Londonderry
BT45 7PE
United Kingdom


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