Tuesday, August 14 | 9:00 am - 12:00 pm
Overview: This presentation, will aid manufacturers of medical devices who intend to modify a 510(k)-cleared device or a preamendments device subject to 510(k)
Why should you Attend: This presentation uses the latest FDA thinking and guidance documents to assist the manufacturers in enhancing the predictability, consistency, and transparency of the “when to submit” decision-making process by providing a least burdensome approach, and describing in greater detail the regulatory framework, policies, and practices underlying such a decision.
Areas Covered in the Session: The main types of changes that might be made to a device: When a manufacturer modifies their device with the intent to significantly affect the safety and effectiveness of a device (for example to significantly improve clinical outcome or to mitigate a known risk) submission of a new 510(k) is likely.
Who Will Benefit: Quality Managers Quality Engineers Regulatory Affairs Small Business Owners
Speaker Profile: Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds.
Event Fee: One Dial-in One Attendee Price: US $290.00
Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com