Abingdon AI & MedTech Brochure

Regulatory, quality and clinical support for medical device manufacturers, Software as a Medical Device (SaMD) developers, AI technology and diagnostics companies, from early development through approval and into post-market compliance, across the US, EU, UK and more than 90 other territories.

The brochure covers our core capabilities: regulatory affairs and market access (FDA 510(k), PMA, De Novo, CE marking, UKCA, MDR and IVDR), AI, software and digital health, quality management systems (ISO 13485, FDA QMSR, MDSAP and ISO 9001), technical documentation, clinical and performance evaluation, and global market access and representation. It includes a case study on achieving full IVDR compliance with no launch delays.