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510(k) Documentation Best Practices for Software or Software Enabled Medical Devices

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Deadline: June 28, 2018 | Date: June 28, 2018

Venue/Country: online event, U.S.A

Updated: 2018-06-10 04:24:22 (GMT+9)

Call For Papers - CFP

This training will remove the mystery of what are the documents that are required to be submitted to ensure a favorable 510K. How to set up the development and documentation environment so that you are compliant to the FDA Requirements and your Medical Device Software documentation does not block your submittal.

This training will also show you how to prevent serious Post Market audit findings that can cause your company serious economic risk.

Areas Covered in the Webinar:

Why is Compliance to IEC62304 essential to preparing software documentation to submit successfully to the FDA for a 510K/

What specific documentation is required for Class B Medical Device Software for submittal?

What Constitutes Compliance

The Key Guidance that the FDA is expecting to be followed within the Software Development and Verification/Validation Process.

What documentation is required to support different Classes of Medical Device Software

Setting up Design Development Documentation correctly to ensure compliance to the standard.

What are the serious legal risks to the Company in not ensuring Compliance with Post Market audits?

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.