- TypeWebinar
- Location Fremont, California, United States
- Date 14-08-2018
Education/Teaching/Training/Development
Medical/Healthcare/Hospital
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: [email protected]
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.
+1-800-447-9407