Invitro Diagnostics

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

  • 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
  • Significant experience with high risk, high complexity assays and instrumentation
  • Detailed knowledge of global IVD regulations
  • Established specialist CRO business that works to successfully set up, monitor and report on global IVD device studies
  • Active membership of BIVDA & TC212 keeps ARC Regulatory at the forefront of IVD industry developments