Medical Devices

ETHOS guides medical device manufacturers through regulatory approval, with particular focus on making the process manageable for small and medium-sized enterprises. Our support covers UK compliance and international certification, so your device can reach markets beyond the UK.

Core regulatory documentation
We prepare the essentials: Technical Files, Quality and Risk Management Systems, and Clinical Evaluation Reports, built to meet the standards your device has to satisfy.

Regulatory representation
We can act as your Person Responsible for Regulatory Compliance (PRRC) and UK Responsible Person, and as your EU Authorised Representative, enabling you to place your product on the European market. Our regulatory team is qualified to act as Qualified Persons under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

UK and NHS compliance
We integrate the DCB 0129 clinical safety standard for the UK NHS with your wider device compliance, and support you across compliance strategy, audit findings, device development, CE and UKCA marking, and the management of recalls, adverse events and post-market vigilance through CAPA processes.

International markets
Our consultancy extends well beyond the UK and EU. We provide US FDA medical device consulting and global regulatory strategy, working to harmonised standards and current state-of-the-art practice, including ISO 13485, IEC 62304, ISO 14971, IEC 82304-1, EN 60601 and EN 62366-1. Where your ambitions reach further, we help you plan and sequence entry into other international markets, building a regulatory roadmap tailored to the requirements of each jurisdiction you are targeting.

Drawing on direct experience working with Notified Bodies, we deliver first-time-compliant solutions tailored to your needs. Every engagement starts by assessing your immediate priorities and building a targeted roadmap, and we work with regulatory and professional bodies to advance best practice across health and care.

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