Regulatory support for the design, development, placement on market, distribution and post-market follow up activities for in vitro diagnostic medical devices to meet various markets.Regulatory support to transition products currently CE Marked under IVDD 98/79/EC to the new IVDR 2017/746 and assist with CE Marking of new products.Providing guidance to assist manufacturers with understanding of UKCA (MDR 2002) and UK Responsible Person requirements.Provide guidance on Quality Management Systems (IS013485), MDSAP (Medical Device Single Audit Programme), US 21CFR, Canadian MDR Part 1, ANVISA and World Health Organization requirements as relates to IVDs and Biologics, where applicable.Regulatory support with gap analyses, generation of and reviewing documentation required for Technical Files including Product Labelling and Instructions for Use requirements.