About
arra.consulting was recently set up by myself, Angela Robertson, to best utilise the knowledge I have obtained from working within the IVD industry to support new product development and provide global market strategy to successfully bring products to market.I am a highly proficient regulatory professional with over 25 years’ regulatory experience in the in vitro diagnostic, medical device and biotechnology industries working with products such as COVID-19 Antigen LFTs, including self-test, POC CD4 LFTs, infectious disease, blood grouping reagents, food IgG testing, allergy testing and associated automation.My regulatory affairs journey started with medical devices in 1995 before I moved to IVD medical devices to assist with the first CE marking of blood grouping reagents when the IVDD 98/79/EC was first introduced and have been with IVDs ever since; latterly as Group RA Director working in all aspects of IVD regulatory affairs and quality systems in an IVD medical device manufacturing business.I've seen a lot of changes in regulatory requirements across the world but my early experience with the FDA and biologics put me in good stead for the ever-increasing world-wide regulatory requirements that have since followed.I completed a MSc in Medical Technology Regulatory Affairs at Cranfield University in 2013, in conjunction with TOPRA, as formal accreditation and to ensure I had a wider breadth of regulatory knowledge of the medical devices industry.My regulatory experience covers the full product life cycle management process from product development, verification and validation, manufacture, registration and post-market activities, resulting in successful Biologics License Applications and 510(k) submissions to the FDA/CBER, as well as successful submissions to Health Canada, Australian TGA and also WHO Prequalification listing and ANVISA approvals, many of which were facilitated by site inspections which I have also supported.My experience has also provided me with a good insight into quality management systems requirements, particularly ISO 13485:2016 but also many other ISO standards as relates to the product life cycle and specifically the requirements needed to meet various markets.