Blue Broccoli GmbH is a leading brand specializing in medical devices regulatory and quality management services. With a focus on compliance and a passion for efficiency, they offer a comprehensive range of solutions to help manufacturers navigate the complex landscape of medical device regulations and streamline their processes. Their services include providing European Authorised Representative (EC-REP), Swiss Authorised Representative (CH-REP), and UK Responsible Person (UK-RP) services, ensuring that manufacturers can access the market quickly and effectively.

In addition, they offer consulting services in quality management systems, product development, sourcing, as well as certification and regulatory support. With years of experience and a track record of success, the Blue Broccoli team has supported startups from zero to CE-certification and obtained FDA 510(k) clearances. Their expertise spans across different medical device classes, and they have built global Quality Management Systems with decentralized R&D and manufacturing setups.

Led by the experienced co-founders David Eiler and Thomas Fässler, the team combines their extensive knowledge to guide clients through the regulatory jungle, allowing them to focus on realizing their product ideas and improving patients' lives. Additionally, Ian Sealey, the UK Partner, brings his expertise in regulatory, quality, technical, and policy consultancy to multinational and start-up medical device manufacturers. If you're looking for a reliable partner to navigate the complex world of medical devices regulatory and quality management, Blue Broccoli GmbH is here to support you every step of the way