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Demonstrated Techniques to a Successful 510k Submission (PL Title)

Summary

  • Different types of FDA submissions and when they can be utilized (Traditional, Abbreviated, Special).
  • When is a 510(k) required?
  • How to find the predicate device?
  • Contents of a 510(k) submission
  • The Refuse to Accept Act
  • The importance of your Design History File to a successful submission.
  • How to maximize your chances of getting your submission cleared.
  • How to make the most of the FDA review window
  • The Catch-Up 510(k)

Overview

For most medical devices, the road to market includes a gate for 510(k) clearance before the device can be marketed.  Completing the product development process and creating the deliverables necessary for submission can take months if not year.   However, once development is completed delays in getting to market can impact the bottom line.   In 2015, only 22% of devices where cleared within the initial 90 day review window.  Only about 60% where cleared within 6 months.  This webinar will explain the 510(k) submission process and provide tips on planning for a successful submission.

Why should attend?

  • Quality System auditors
  • Engineering managers and personnel
  • Regulatory Affairs
  • Product development engineers

Mercedes Massana

Expert

Mercedes Massana, is the founder and CEO of MDM Engineering Consultants, a consulting firm that provides engineering and quality consulting services in the medical device, biotechnology, and pharmaceutical industries. Mercedes has over twenty-five years of experience in the Medical Device industry. Extensive experience in developing processes within the constraints of FDA/lSO Quality Systems. She has been responsible for establishing processes and leading groups of engineering in the following disciplines: Risk Management, Requirements Management, Verification and Validation, Process Improvements, Project Management, Software Systems Validation, Process Validation. Mercedes is an ASQ certified Biomedical Auditor (CBA), Software Quality Engineer (CSQE), Quality Manager (CQMa) and Quality Auditor (CQA). Mercedes is well versed in FDA and ISO regulations.

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