Medical Devices

ETHOS offers comprehensive expertise in navigating the complexities of medical device regulatory approvals, specialising in streamlining the compliance process for small to medium-sized enterprises. Our services extend beyond domestic compliance, providing strategic guidance for international certification of medical devices.

Our offerings include the preparation of Technical Files, Quality and Risk Management Systems, and Clinical Evaluation Reports. We offer representation as the Person Responsible for Regulatory Compliance & UK Responsible Person, and can act as your EU Authorised Representative to market your product in the European Union.We ensure seamless integration with the DCB 0129 Clinical Safety standard for the UK NHS, alongside devising comprehensive compliance strategies, addressing audit findings, assisting with device development, CE marking, and managing recalls, adverse events, and post-market vigilance through CAPA processes.

Our consultancy also encompasses US FDA Medical Device Consulting and Global Regulatory Strategy, adhering to Harmonised Standards and managing state-of-the-art practices in line with ISO 13485, ISO 62304, ISO 14971, ISO 82304, EN 60601, and EN 62366. Leveraging our industry experience and insights gained from working with Notified Bodies, we deliver first-time compliant solutions tailored to your business needs. Our regulatory team is qualified to act as ‘Qualified Persons’ under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), ensuring your products meet the highest standards of safety and efficacy. At ETHOS, we assess your immediate needs to create a targeted roadmap, collaborating with regulatory and professional bodies to champion best practices within the health and care sector.

Contact us today for your free initial diagnostic conversation or Health Check to discuss your certification or compliance challenges.