Quality First International

Quality First International (QFI) is a global consultancy specialising in medical device regulation and compliance. Since 1995, we have supported clients across the UK, Europe, the U.S. and Canada, ranging from start-ups to multinationals. We help bring your medical device to market by solving regulatory, technical and compliance challenges with deep industry expertise and hands-on support. Our core services include: • Global regulatory & compliance strategy • Product development & scientific support • Microbiology & biocompatibility • Quality Management Systems • EU Authorised Representative & UK Responsible Person • Device registration & clinical trials Technologies we support include: • Cosmetic & combination products • Cardiovascular & minimally invasive devices • Implants & animal-derived devices • PPE, clinical monitors and more Whether you need guidance on a single submission or end-to-end QMS implementation, QFI has the experience to help you navigate complex regulatory pathways with confidence.