WEBINAR · ON-DEMAND
This presentation examines the International Medical Device Regulators Forum (IMDRF), its functions, and contemporary industry developments regarding FDA collaboration on cybersecurity. It addresses common questions about cybersecurity considerations for new regulatory submissions and outlines current expectations.
Key Takeaways
- IMDRF overview and organizational functions
- FDA collaboration initiatives on medical device cybersecurity
- Cybersecurity trends and developments affecting the industry
- Frequently asked questions regarding cybersecurity in regulatory submissions
- Current regulatory expectations for cybersecurity compliance
Speakers
Lawson Cline
Omnex Consultant, Manufacturing Quality & Quality Management Systems
Lawson Cline is an Omnex consultant with experience focused in Manufacturing Quality and Manufacturing Quality Management. Lawson spent 15 years developing products and processes as a Manufacturing Engineer and Engineering Supervisor. During his work in the contract manufacturing environment, there was a high emphasis was put on product integrity. Additionally, the implementation of ISO standards was a natural course of action for improvement measures for the suppliers of leading medical device companies in the Twin Cities metro area where Lawson focused his energy. Lawson also has 16 years of experience in Quality where he held roles in Supplier and Quality Engineering and roles in Quality management. Lawson also actively helped support the development, changes, and improvements needed for those quality management systems. He has experience auditing as a 1st and 2nd party auditor to ISO 9001, IATF 16949, and ISO 13485.