The 510(k) Process and Risk Management

Instructor: Edwin L Bills
Product ID: 701497
Training Level: Advanced
  • Duration: 90 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Jun-2014

Training CD / USB Drive

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(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

This 510(k) and risk management webinar will discuss FDA expectations for information supplied in the 510(k) application and how to best demonstrate that product is safe.

Why Should You Attend:

The majority of medical devices being placed on the US market are cleared through the Premarket Notification or 510(k) process. FDA has continued to change this process after some controversy surrounding devices cleared for market. This controversy resulted in replacement of the Director of the Center of Devices and Radiological Devices. An internal report identified some issues and called for an external review of the process, which the FDA commissioned. Manufacturers need to continue to monitor the FDA communications on the 510(k) process.

This webinar will discuss FDA concerns in medical device safety expressed in reports on 510(k) products. The 510(K) process has begun to change and it is certain the process will continue to change. Manufacturers need to be prepared to defend medical device safety in their premarket applications. One of the tools that can be used to address the concerns over product safety that drives the FDA changes is Risk Management. We will discuss FDA expectations for information supplied in the 510(k) application and how to best demonstrate the product is safe.

Areas Covered in the Webinar:

  • What concerns were revealed in the internal report on the 510(k) process?
  • What information can be gained from congressional statements?
  • What is a "predicate" product in the 510(k) process?
  • How can a manufacturer determine if the proposed product is as safe as the predicate device?
  • How can a manufacturer best provide documentation in the 510(k) application demonstrating product safety?
  • Current 510(k) process
  • Changes to FDA 510(k) cleared product

Who will benefit:

The webinar is focused on the safety requirements of the US FDA Premarket Notification (510(k)) process, and applies to the manufacturers personnel responsible for creating documentation supporting the application. It is not limited to regulatory affairs personnel, but includes all of the design team that creates the document package.
  • Regulatory Affairs
  • Risk Managers
  • Risk Management team members
  • Quality Engineering
  • Market Research
  • Clinical
  • MDR Reporters

Instructor Profile:

During his 26 year career in medical devices, Edwin Bills has held a number of quality and regulatory affairs positions. Mr. Bills is ASQ Certified as Quality Engineer, Quality Auditor, and as Manager of Quality/ Organizational Improvement. He also holds a certificate as Regulatory Affairs Certified through the Regulatory Affairs Professionals Society, and a BS and Master’s degree from the University of Cincinnati. Recently, Mr. Bills served as US Industry Co-chair of the Association for Advancement of Medical Instrumentation committee, QM/WG04, on application of risk management to medical devices and is a current member of the international technical committee. Mr. Bills has presented at training courses for the American Association of Medical Instrumentation (AAMI) in the area of risk management and quality systems. Currently, Mr. Bills is the Principal Consultant at ELB Consulting in the area of medical device quality, regulatory, product liability and risk management.

Follow us :
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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email call +1-888-717-2436 (Toll Free).

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