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A Comprehensive View of FDA Regulations for Medical Devices

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Website | Edit Freely


Deadline: February 24, 2020 | Date: March 05, 2020-March 06, 2020

Venue/Country: San Diego, CA, U.S.A

Updated: 2020-01-02 23:35:19 (GMT+9)

Call For Papers - CFP

Don’t let a common misunderstanding get you into trouble! There is more to the US Medical Device Regulations than Part 820.

Companies that don’t understand will face regulatory scrutiny and receive FDA Form 483s and Warning Letters. Recently a device manufacturer got a Warning Letter relating to updates to shipped devices, which said, “The Quality Manager stated he was unaware of the corrections and removal reporting and recordkeeping requirements.”

This two day interactive course on FDA regulations for medical devices will:

Cover more than just the Quality Management System

Provide an overview of regulations and how they fit together

Explain Unique Device Identification (UDI) in detail, covering the issues device manufacturers will face as well as timeline for implementation

Help attendees understand the four major elements of the US regulatory structure: laws, regulations, guidance, and consensus standards

Teach the current device marketing regulations

Discuss how to handle FDA inspections and effectively respond to inspectional observations and 483s

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.