QRA Medical

QRA Medical is a Birmingham-based quality, regulatory and clinical consultancy founded by Karandeep Singh Badwal. It advises medical device and digital-health companies on EU MDR, IVDR, UK and FDA pathways, including 510(k), De Novo and PMA strategy. Services also include ISO 13485 quality systems, gap assessments, PRRC support, clinical evaluation reports, PMCF planning, literature review and compliance for software and AI-enabled medical devices.