Demonstrated Techniques to a Successful 510k Submission
Duration : 90 Minutes
Mercedes Massana,
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 develo Read more
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.
Course Objectives:
This webinar will explain the 510(k) submission process and provide tips on planning for a successful submission.
Course Outline:
• 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)
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
This webinar will provide valuable assistance to medical device companies in managing their Design History Files. The employees who will benefit include:
• Quality System auditors
• Engineering managers and personnel
• Regulatory Affairs
• Product development engineers
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
100% MONEY BACK GUARANTEED
Refund / Cancellation policyGet In Touch
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