Coupe Associates

Coupe Associates is a specialized consultancy firm providing regulatory affairs, quality assurance, and clinical affairs services to the medical device, in vitro diagnostic (IVD), and pharmaceutical industries. Based in the United Kingdom, the company assists global clients in navigating complex regulatory landscapes, including CE marking, UKCA marking, and FDA 510(k) submissions. Their expertise covers the implementation of Quality Management Systems (QMS) such as ISO 13485, technical documentation preparation, and post-market surveillance strategies. The firm serves as a strategic partner for companies seeking to bring innovative healthcare technologies to market while ensuring compliance with international standards. They also provide training and auditing services to ensure ongoing adherence to global regulatory requirements.