• 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 medical 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.

  • ARC Regulatory - Your integrated in vitro diagnostics life-cycle partner

    Experts in delivering compliant regulatory, clinical and quality management solutions to manufacturers in the IVD (In Vitro Diagnostics) 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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Customer Satisfaction Survey 2019 Fri, 15 Mar 2019 8:34 Customer Needs Survey 2019 Fri, 15 Mar 2019 8:26 Latest From ARC
Our Team of IVD & Medical Device Consultants

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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