Meet the Speakers
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.
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.
