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

    Our team of expert consultants keep fully up to date with constantly evolving regulatory requirements, and are dedicated to ensuring that our clients are fully compliant at all stages of the medial device life-cycle. ARC works to fully understand your business, allowing us to develop tailored regulatory and clinical solutions that deliver on your 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. ARC are actively involved in the development of a new ISO standard for Clinical Performance Studies, helping to future-proof your clinical evidence strategy.

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  • Unparalleled experience in companion diagnostics

    Our specialist CRO unit brings significant experience in the area of CDx, global regulatory strategies & submissions, clinical affairs and global clinical site monitoring.

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  • Experts in active and non-active medical device requirements

    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 labelling.

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  • All-Ireland IVD Symposium 2017

    View our photo gallery, and find out more about our 2017 Symposium which took place on 4th May at Citywest Hotel Dublin.

    News from our 2017 Symposium on 4th May


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In Partnership

Fish and chips; Laurel and Hardy, salt and pepper - some things 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 Medical Device industry.

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