Navigating IVDR compliance: Practical insights and strategies for long-term success

In this DNV webinar, our IVDR experts shared practical guidance to help IVD manufacturers navigate the complex path to certification and long-term compliance. The session explored current challenges under the In Vitro Diagnostic Regulation (IVDR), best practices for technical documentation, and how digital tools can simplify and strengthen compliance efforts.

Our expert panel included:

• Dr. Kenneth Fuh, IVDR Technical Manager, Region Americas, DNV
• Anne Geirsdatter Hviding, IVDR Program Manager, DNV
• Dr. Ramdas G. Bhong, Group Leader IVDR, DNV
• Dr. Ajay Abhyankar, Certification Manager IVDR, DNV

The transition to IVDR represents one of the most significant regulatory shifts for the IVD industry. With stricter requirements, evolving timelines, and increased documentation expectations, manufacturers face growing complexity in achieving and maintaining compliance.

From understanding the certification process to implementing digital solutions that enhance efficiency, our experts provided actionable insights and real-world examples to support manufacturers in reaching compliance with confidence.

How can your organization prepare for long-term IVDR success?
Watch the recording to hear our experts’ insights and practical strategies.