Sign for Notice Everyday    Sign Up| Sign In| Link|

Our Sponsors

  • ESTA - Electronic System for Travel Authorization
Receive Latest News

Feedburner
Share Us

When to Submit a 510(k) for a Change to an Existing Device

View: 31

Website http://www.compliance4all.com/control/w_product/~product_id=502023LIVE?channel=ourglocal_Aug_2018_SE | Edit Freely

Category FDA 510K Changes, fda 510 k database, fda medical device, Compliance Trainings, fda 510 k guidance documents, vitro diagnostic devices, Regulatory Agency Investigators

Deadline: August 12, 2018 | Date: August 14, 2018

Venue/Country: Online, U.S.A

Updated: 2018-06-07 14:31:44 (GMT+9)

Call For Papers - CFP

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


Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.