• Expert solutions to medical device companies of all sizes, from start-ups to multi-nationals

    Our team of highly experienced consultants keep fully up to date with constantly changing regulatory requirements and are dedicated to assuring our clients are fully compliant at all stages of the medial device life-cycle. Our mission is fully understand your business and develop solutions to ease the burden on IVD and medical device companies, whilst offering a customer-centred approach that delivers on strategic and commercial goals.

  • Your integrated in vitro diagnostic life-cycle partner

    Experts in delivering compliant regulatory, clinical and quality management solutions to manufacturers in the IVD sector, across multiple technologies and analytes.

    Learn More
  • Unparalleled experience in companion diagnostics

    Significant and unrivaled body of experience in the CDx space across global regulatory strategies & submissions, clinical affairs and independent clinical site monitoring.

    Learn More
  • Experts in active and non-active medical device requirements

    We have a detailed knowledge in a range of vertical and horizontal international standards applicable to medical technologies, from risk management and usability engineering to electrical safety and labeling.

    Learn More
  • Join Us on the 4th May 2017 for the first All-Ireland IVD Symposium in Citywest Hotel Dublin

    Whether you are an early start-up, or work for a larger IVD manfacturer, ARC Regulatory and our team of expert collaborators, ARC Regulatory will help you to ascertain the immediate and long-term effects of The new EU IVD regulation on your business.

    Book Your Place Now

In Partnership

Fish and chips; Laurel and Hardy, salt and pepper - Somethings just work better with a companion. Here at Arc Regulatory our primary goal is to work as your partner; easing the journey towards regulatory compliance for companies in the Medical Device and In Vitro Diagnostic industry.

Learn More