Ed retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. He was involved in the development of products such as IVD devices, kidney dialysis systems and inhalation devices. His QS experience includes, design control, risk analysis, CAPA, softwa Read more
Preparing a submission to get FDA approval for a new product is
More than half of all submissions are rejected. We will teach you how to prepare a submission
Course Objectives:
We will explain what a 510(k) is and the procedure to prepare the submission. The several types of 510(k) will be explained. Each part of the submission will be explained. The very confusing concepts of predicate device and substantial equivalence will be discussed.
How to find an acceptable predicate device will be taught. FDA places special emphasis
Course Outline:
• Unique terminologies in 510(k)
• What is Refuse To Accept policy
• What is a predicate device
• Selecting a predicate device (substantial equivalence)
• Where to find substantially equivalent predicate devices
• How to handle software
• 510(k) procedure for device modifications
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Engineering Personnel
• QA
• Software Developers
• Management
• Regulatory Personnel
6-Hour Virtual Seminar on Computer System Validation for Cloud and COTS Applications
LIVE : Scheduled on
17-May-2024 :11:00 AM EDT
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2-hr Virtual Seminar: FDA Inspections - Understanding the Core Elements
LIVE : Scheduled on
20-May-2024 :01:00 PM EDT
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21 CFR 58 - Good Laboratory Practice (GLP) and USP 1058 Validations
LIVE : Scheduled on
30-May-2024 :01:00 PM EDT
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6-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?
LIVE : Scheduled on
18-June-2024 :11:00 AM EDT
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6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA
LIVE : Scheduled on
19-June-2024 :11:00 AM EDT
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