Upcoming Webinar

Insight into the EMA CDx Review Pilot Program for IVDR Certification

Wednesday, October 6, 2021 | 9:30 a.m. Central US Time / 4:30 p.m. Central EU Time

James Hewitt, IVD Product Expert, TUV SUD

This webinar will have a 30 minute presentation followed by 10 to 15 minutes of Q&A.

  • Actors involved in the program & collaborative work focus
  • Prioritizing legacy products to ensure continued accessibility
  • Clarifying key points of the EMA review: IFU, SSP & more
  • Program timeline thus far & forecast of next steps
  • Core learnings & takeaways from the pilot

$249 for 1, $395 for up to 3 people

Combination Products
Regulatory Affairs
Clinical Research
Performance Evaluation
Quality Assurance



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James Hewitt
SIVD Product Expert

James Hewitt is an IVD Product Expert and Senior Product Specialist for CDx devices at TUV SUD. As part of his role, James is a member of the CDx technical working group, comprising EMA and Notified Body representatives, whose main goal is to develop procedural guidance on the consultation of EMA by NB on CDx devices. Prior to joining TUV SUD, James has 10 years’ experience in the design and development of numerous CDx devices for the EU and US markets, predominantly within the oncology field.  

For More Information, Contact:

Brooke AkinsBrooke Akins
Division Director, Life Science Programs
+1 (312) 224-1693