More than 3,000 medical device manufacturers worldwide rely on DNV to support their quality, certification and market access needs across multiple jurisdictions. We work with you to manage risk, protect patients and users, and demonstrate compliance with demanding regulatory requirements.
Our services span the full lifecycle of your devices and your quality management system. We provide ISO 13485 certification and MDSAP (Medical Device Single Audit Program) certification to give a solid foundation for global market access. Through our notified bodies – DNV Product Assurance and DNV MEDCERT – we deliver conformity assessment for MDR and IVDR, UKCA certification for the UK market, and TCP III services that support access to additional third-country markets.
Combining technical, digital, risk and clinical competence, we help you work in more efficient and effective ways. Our experts assess your quality management, technical documentation and product performance, and we collaborate with your teams to turn regulatory requirements into structured, manageable improvement actions.
As devices become more connected and software-driven, we place particular emphasis on cybersecurity, usability, AI and data integrity. Our independent certification and notified body services help you build trust in your products, reduce nonconformities and recalls, and sustain compliance over time – so that patients, healthcare professionals and regulators can have confidence in the medical devices they depend on.
