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Updates on the IVDR


In this episode of the RAQA Café Podcast, our host engages with Warren Jameson (NAMSA’s Sr. Manager, Regulatory & Quality) and Christele Perrin-East (NAMSA’s Sr. Regulatory Consultant, IVD), to explore the extension of the EU IVDR deadline and its implications for the industry.

Our experts highlight the importance of maintaining progress towards IVDR compliance and registration despite the delay. The discussion also reflects on lessons learned from the EU MDR and examines how the IVDR extension might impact both new product registrations and updates to existing products previously regulated by the EU IVDD.

“I think manufacturers have to be very careful when they look at the dates. It’s not actually that far, because if you work backwards, like 2025 is actually. If you can’t 12 or 18 months period to get a technical file reviewed, you have to send your technical file like almost right now.” -Christelle Perrin-East, Sr. Regulatory Consultant

Key Discussion Topics:

  • The IVDR Extension
  • Lessons from the MDR
  • Negative Impact of the IVDR Extension • Impact on Existing Products Covered by the IVDD



Blog – Navigating the Transition: Understanding the EU’s Proposed Amendments to IVDR

Blog – MDCG 2022-11Rev 1: Urgency for MDR and IVDR Compliance

RAQA Café Podcast – The EU IVDR: What Do You Need to Know?


*Please note that the opinions discussed throughout the podcast are their own and do not reflect those of their current or former employers.


Meet the Speakers


Christèle East, PhD

Christèle Perrin-East, PhD; Senior IVD Regulatory Consultant , NAMSA

Christèle currently serves as a Senior Regulatory Consultant (IVD) at NAMSA. She has been in the MedTech industry for over 20 years with 10 years focused on IVD products. She gained experience on IVD product development in small biotechnology companies, including AmikanaBioLogics and HalioDx.

Before joining NAMSA, Christèle worked for nexialist, a consulting company specializing in regulatory intelligence and compliance of health products. As a Medical Device and IVD consultant, she was involved in ensuring compliance with classification, technical documentation for CE marking, performance evaluation within the framework of IVDD and IVDR, regulatory support; and biological risk assessment (plan & report), clinical evaluation and PMS for Medical devices.

Warren Jameson, PhD; Senior Manager-Regulatory and Quality, NAMSA

Warren has been in the industry for 7 years with 5 years focused on IVD and companion diagnostics.  Warren’s experience is in the development of Quality Controls for assays such as Clinical Biochemistry, Hematology, Lipid, Cardiac, Immunology, Endocrinology and Pediatric. As project lead, he focused on the full R&D cycle of his developed products from scope, feasibility, verification and validation leading to CE mark.

Prior to joining NAMSA, Warren worked for Randox Laboratories in the UK. With Randox, Warren held a variety of roles from R&D Scientist, Project Lead and Quality/Regulatory Affairs Manager. As QM, Warren was responsible for regulatory compliance in clinical operations for Randox’s public health check branch. This gave Warren significant experience in regulatory compliance with relevant legislation such as ISO 9001:2015, ISO 13485:2016, ISO 14971:2012, GDPR and developing/governance of the Quality Management System. Furthermore, developing policy within the company on a large range of issues which include Health and Safety, Data protection, Privacy and Quality. Moreover, audit experience both internally and externally such as audits of suppliers.

Rich Granquist

Richard Granquist; Senior Quality System Consultant, NAMSA

Rich Granquist has 17 years of experience in the medical device industry and has spent extensive time working with both start-up manufacturers and larger, global device manufacturers. He specializes in quality system development and risk management.

Rich started in the medical device industry as a Microbiologist focusing on preclinical testing including, packaging validation, biocompatibility testing and reprocessing instruction validation for urology and women’s health devices. He spent several years as a Quality Engineer performing complaint investigations, root cause investigation and product development focusing on aortic intervention vascular devices. In 2014, Rich joined NAMSA as a Quality Systems Consultant. Over his 16 years in the medical device industry, he has participated in numerous AAMI ISO standards committees and currently sits on the AAMI working groups for AAMI ISO 14971, AAMI ISO/TR24971, AAMI ISO 13485 and AAMI ISO 15223.