ARC Regulatory has a specific focus on in vitro diagnostic medical device consultancy, with a significant proportion of our clients being leaders in the IVD medical device industry.

ARC Regulatory’s consultants have significant experience across multiple in vitro diagnostic technologies and disease areas, from self-test blood glucose monitoring, blood borne virus and tissue transplant assay, including complex software-driven instrumentation.

Working with global market leaders, our dedicated IVD team has industry-leading regulatory expertise, resulting in the ability to develop a comprehensive understanding of your needs and challenges to develop pragmatic, compliant solutions.

Our expertise

  1. Specific focus on in vitro diagnostic medical devices, with the technical knowledge and industry experience to understand and meet the challenges specific to the in vitro diagnostic sector
  2. Significant experience with high risk, high complexity assays and instrumentation
  3. Detailed knowledge of global IVD regulations
  4. Established specialist CRO business that works to successfully set up, monitor and report on global IVD device studies
  5. Active membership of BIVDA & TC212 keeps ARC Regulatory at the forefront of IVD industry developments