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- Regulatory Affairs Specialist
- Quality Assurance Manager
- Medical Device Engineer
- Clinical Affairs Associate
- Product Development Manager
- Regulatory Compliance Officer
- Quality Systems Auditor
- R&D Engineer
- Medical Device Consultant
Mastering FDA 510(k) and PMA Submissions: A 3-Hour Virtual Seminar for Faster Approval
Are You Struggling with Delays and Setbacks in Your 510(k) or PMA Submissions?
Instructor :
Charles H. Paul
Webinar ID:
11906
Date: DEC 24, 2024 (TUE)
Start Time: 10 AM PT - 1:00 PM PT
Duration: 3 Hrs.
What will you learn
-
- Understanding Medical Device Classifications and Their Importance
- Navigating 510(k) And PMA Submission Processes
- Exploring Current EU Regulatory Requirements And CE Marking
- Insights Into IDEs And HUDs Submission Processes
- Improving Submission Quality For Faster Approval
- Essential Steps For Preparing A Successful Application
- Common Pitfalls And Strategies To ….
-
- Understanding Medical Device Classifications and Their Importance
- Navigating 510(k) And PMA Submission Processes
- Exploring Current EU Regulatory Requirements And CE Marking
- Insights Into IDEs And HUDs Submission Processes
- Improving Submission Quality For Faster Approval
- Essential Steps For Preparing A Successful Application
- Common Pitfalls And Strategies To Prevent Them
- Quality System And Product Certification Essentials
- Creating And Managing Technical Files And Dossiers
Course Description
Navigating the FDA’s medical device submission process can be complex, with thousands of applications reviewed each year.
Shortening time to market is crucial, but this can only be achieved after ensuring that the device is safe, effective, and meets its intended use.
Common challenges include:
-
- Poorly structured or disorganized submissions.
- Missing essential information or not meeting regulatory requirements.
- Inconsistencies that lead to delays in approval and extend the time to market.
This 3-hour webinar is designed for new professionals in the medical device industry who need a foundational understanding of the 510(k) and PMA submission processes.
By attending, you will:
-
- Gain insights into structuring and organizing your submissions effectively.
- Learn best practices for ensuring compliance with regulatory requirements.
- Understand common pitfalls that can delay the approval process.
This seminar serves as an essential precursor to more advanced training, setting you up for success in the medical device regulatory landscape.
Enroll Now!
Navigating the FDA’s medical device submission process can be complex, with thousands of applications reviewed each year.
Shortening time to market is crucial, but this can only be achieved after ensuring that the device is safe, effective, and meets its intended use.
Common challenges include:
-
- Poorly structured or disorganized submissions.
- Missing essential information or not meeting regulatory requirements.
- Inconsistencies that lead to delays in approval and extend the time to market.
This 3-hour webinar is designed for new professionals in the medical device industry who need a foundational understanding of the 510(k) and PMA submission processes.
By attending, you will:
-
- Gain insights into structuring and organizing your submissions effectively.
- Learn best practices for ensuring compliance with regulatory requirements.
- Understand common pitfalls that can delay the approval process.
This seminar serves as an essential precursor to more advanced training, setting you up for success in the medical device regulatory landscape.
Enroll Now!
Why you should attend
In today’s fast-paced healthcare landscape, medical devices are evolving rapidly, integrating advanced technologies like AI, software, and biotechnology.
With this evolution comes the growing complexity of regulatory submissions, making it crucial for professionals to stay ahead of the curve.
A misstep in the submission process can lead to delays, increased costs, and even lost market opportunities.
Key Pain Points Addressed in This Webinar:
-
- Navigating Complex Regulations: Understand the intricacies of the 510(k) and PMA processes to avoid common pitfalls that can delay approvals.
- Global Market Entry: Learn how to compare and contrast US and EU regulations, giving you a strategic advantage in the global marketplace.
- Accurate Device Classification: Discover the importance of correctly classifying your medical device to streamline the approval process and avoid costly mistakes.
What You Will Gain:
-
- Hands-on Strategies for crafting regulatory submissions that are clear, compliant, and compelling, reducing the risk of rejection.
- Expert Insights into quality system certifications and creating technical files, empowering you to manage compliance with confidence.
- Practical Skills to enhance your role, whether you’re in regulatory affairs, quality assurance, or product development, making you an invaluable asset to your team.
By attending this seminar, you’ll not only master the submission process but also position yourself as a key player in bringing innovative medical devices to market faster, safely, and more effectively.
Join Now!
In today’s fast-paced healthcare landscape, medical devices are evolving rapidly, integrating advanced technologies like AI, software, and biotechnology.
With this evolution comes the growing complexity of regulatory submissions, making it crucial for professionals to stay ahead of the curve.
A misstep in the submission process can lead to delays, increased costs, and even lost market opportunities.
Key Pain Points Addressed in This Webinar:
-
- Navigating Complex Regulations: Understand the intricacies of the 510(k) and PMA processes to avoid common pitfalls that can delay approvals.
- Global Market Entry: Learn how to compare and contrast US and EU regulations, giving you a strategic advantage in the global marketplace.
- Accurate Device Classification: Discover the importance of correctly classifying your medical device to streamline the approval process and avoid costly mistakes.
What You Will Gain:
-
- Hands-on Strategies for crafting regulatory submissions that are clear, compliant, and compelling, reducing the risk of rejection.
- Expert Insights into quality system certifications and creating technical files, empowering you to manage compliance with confidence.
- Practical Skills to enhance your role, whether you’re in regulatory affairs, quality assurance, or product development, making you an invaluable asset to your team.
By attending this seminar, you’ll not only master the submission process but also position yourself as a key player in bringing innovative medical devices to market faster, safely, and more effectively.
Join Now!
Areas Covered
-
- Medical Device Classifications
- 510(k) and PMA Processes
- Current EU Regulatory Requirements
- CE Marking
- Investigational Device Exemptions (IDEs) and Humanitarian Use Devices (HUDs)
- Improving Content and Submission Quality
- What to Ensure While Preparing for an Application
- Common Pitfalls and How to Prevent Them
- Do’s and Don’ts of Regulatory Submissions
- Quality System Certification
- Product Certification
- Technical Files and Dossiers
BONUS:
-
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
- Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.
-
- Medical Device Classifications
- 510(k) and PMA Processes
- Current EU Regulatory Requirements
- CE Marking
- Investigational Device Exemptions (IDEs) and Humanitarian Use Devices (HUDs)
- Improving Content and Submission Quality
- What to Ensure While Preparing for an Application
- Common Pitfalls and How to Prevent Them
- Do’s and Don’ts of Regulatory Submissions
- Quality System Certification
- Product Certification
- Technical Files and Dossiers
BONUS:
-
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
- Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.
Who is this course for
Everybody benefits from watching this. Even better when done as a group!
Everybody benefits from watching this. Even better when done as a group!
-
- Regulatory Affairs Specialist
- Quality Assurance Manager
- Medical Device Engineer
- Clinical Affairs Associate
- Product Development Manager
- Regulatory Compliance Officer
- Quality Systems Auditor
- R&D Engineer
- Medical Device Consultant
Instructor Profile
Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles has been a regulatory consultant for over 20 years and has published numerous white papers on the subject. The firm works with both domestic and international clients designing solutions for complex training and documentation issues.
Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles has been a regulatory consultant to the life sciences industry for over 20 years and has published numerous white papers on the subject. The firm works with both domestic and international clients designing solutions for complex human performance and compliance-related problems.
