ETHOS provides expertise for all aspects of medical device regulatory approval.
We are specialists in simplifying regulatory compliance for small and medium-sized enterprises, our services also include regulatory strategy should you be looking to certify your device in other countries.
Compliance work includes:
• Technical Files, Quality and Risk Management Systems, Clinical Evaluation Reports
• Person Responsible for Regulatory Compliance & UK Responsible Person
• Integration with DCB 0129 (UK NHS) Clinical Safety standard
• Compliance Strategy
• Remediating audit findings
• Device development and CE marking
• Recalls and Adverse Event management, Post Market Vigilance and CAPA
• US FDA Medical Device Consulting
• Global Regulatory Strategy
• Harmonised Standards & State of the art management – ISO 13485, ISO 62304, ISO 14971, ISO 82304, EN 60601, EN 62366
Our experience within the medical device industry and from working for Notified Bodies, enables us to provide solutions that work for you and your business that are compliant with the regulators, first time. Our medical device regulatory team is qualified to act as ‘Qualified Persons’ in line with the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
ETHOS will assess your most immediate needs and develop a roadmap to support your compliance work requirements. The team collaborate regularly with regulatory bodies and professional standards organisations to influence best practice across the health and care sector.