DNV Product Assurance Services
DNV Product Assurance (NB #2460) is a trusted Notified Body providing certification and conformity assessment services for medical products, helping customers ensure safety, drive innovation, and meet regulatory requirements.
DNV Product Assurance Services
Challenges in medical device compliance
Global product safety and compliance requirements are more stringent and complex than ever. In sectors such as medical devices, industrial machinery, and high-tech equipment, manufacturers must demonstrate not only quality but full regulatory conformity across global markets.
Regulations like the EU MDR and IVDR demand continuous oversight, transparency, and trusted third-party validation. With innovation accelerating, having a competent, impartial, and technically skilled assurance partner is essential to placing safe, compliant products on the market – consistently and efficiently.
Our medical device certification services
DNV Product Assurance is a globally recognized Notified Body (NB 2460) delivering certification services across a broad range of medical device regulations.
We specialize in:
-
Certification under EU MDR (2017/745) and EU IVDR (2017/746).
-
ISO 13485 and ISO 9001 quality system certification.
-
MDSAP certification.
-
TCP III Certification.
-
Lifecycle compliance support.
Our work ensures your products meet applicable safety, performance, and regulatory requirements so they can be brought to market and maintained with confidence.
Trusted experts in medical devices
With more than 160 years of trust and independence, DNV is your reliable partner in product assurance. We combine regulatory rigor with industry insight and technical depth to deliver meaningful and efficient certification outcomes.
Our approach is collaborative, transparent, and rooted in safety, risk management, and innovation. Whether you are launching a breakthrough device or navigating a complex compliance journey, we are here to help you succeed on time and in full compliance.
Benefits of our medical device services
- Secure and maintain market access in the EU and beyond.
- Reduce time to market with streamlined certification processes.
- Mitigate risks through expert, third-party assessments.
- Strengthen brand credibility and stakeholder confidence.
- Stay ahead of evolving regulations with up-to-date guidance.
- Access combined system and product certification under one roof.
