SME Profile

Carole Stamp


27 years of experience in Medical Devices and In Vitro Diagnostics in a variety of functions for industry (Research, Manufacturing, Engineering and Regulatory Affairs), a Notified Body, and a consulting firm.

 

Sr. Principal Advisor and VP of Regulatory Affairs & Quality Systems at a consulting firm until 2009 providing guidance on all aspects of quality system implementation and compliance, as well as, regulatory strategies, submissions, and negotiations with Notified Bodies and the FDA.

 

Regional Operations Manager for the Notified Body TÜV Product Service Inc until 2000 providing Notified Body Auditor services for CE certification to the MDD, AIMD, and IVD directives.  Also responsible for the FDA 510(k) Third Party Reviewer program.

 

Held various management and individual contributor positions at 3 major IVD companies until 1996.

Speaker and instructor in areas of Regulatory Affairs and Quality Systems.



Courses: By this SME
 
Electronic Instructions for Use of Medical Devices in the European Union
ISO 13485:2016 - Medical Devices Quality Management Systems Requirements for Regulatory Purposes
How to Navigate Through the ISO 13485 Certification Process
Internal Auditor Training for Medical Device Manufacturers
The European Union Regulatory System for Medical Devices
US FDA Investigational Device Exemption (IDE) Overview
Introduction to the US FDA
Steps to CE Mark
Labeling Requirements for Medical Devices in Europe
Labeling Requirements for Medical Devices in the US
US FDA 510(k) Notification Process
Introduction to the EU Regulatory System
The Main Concepts for Safe and Performing Devices










Subject Matter Expert