Linda assists customers with regulatory issues and challenges, including implementation of UDI processes.
Connect with Me
Linda Chatwin, J.D., RAC – Senior Customer Solutions Consultant
Ms. Chatwin has been involved with regulated medical products for over 30 years. She understands the regulatory maze required to bring products to market. She holds a Regulatory Affairs Certification and is holds a Juris Doctor degree. She has obtained product approvals for a wide range of products, and remains involved in changing requirements for medical devices worldwide. Currently, she heads the North American Advisory Services group for UL, LLC, assisting clients with regulatory issues and challenges, including implementation of UDI processes. Ms. Chatwin travels worldwide to speak about changing market access issues.
My Published Resources
PRE-RECORDED WEBINAR: Meeting new FDA Expectations for ISO 18562 VOC and Particle Testing for Medical Devices
Poll reveals manufacturers not ready for 2019 ISO 13485:2016 transition
PRE-RECORDED WEBINAR: Understanding the Transition from MDD to MDR
EU Council adopts new MDR and IVDR
Dealing with legacy devices in a constantly evolving regulatory environment
Preparing for the EU Medical Device Regulation
PRE-RECORDED WEBINAR: Impact of the New FDA Guidance on 3D Printed Medical Devices
Common Questions for Working on FDA Responses
Common Questions about ISO 13485:2016
PRE-RECORDED WEBINAR: ISO 13485:2016 – Change? Do I Have To?
Common Questions After an FDA Inspection
Video: Approvals of Medical Devices for the U.S. Market
PRE-RECORDED WEBINAR: Workin’ the FDA Response! Now What?
Webinar Recording: FDA Just Left! Now What?
Major Revisions to ISO 13485:2016
Common Challenges for Manufacturers Making 510(k) Submissions
Strategies for Facilitating 510(k) Device Review
What’s involved in an FDA inspection
PRE-RECORDED WEBINAR: FDA Just Called! Now What?
Requirement for U.S. FDA Unique Device Identification
Key Information Requirements of an FDA 510(k) Submission