ComplianceOnline

The IDE (Investigational Device Exemption) - It's Purpose and Preparation

Instructor: John E Lincoln
Product ID: 701087
  • Duration: 60 Min

recorded version

$299.00
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: Nov-2008

Training CD / USB Drive

$500.00
One CD/USB is for usage in one location only.
(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 IDE (Investigational Device Exemption) webinar will cover its purpose and preparation recommended subject headings and content Submission and follow up Usage in the clinical trial(s).

The U.S. FDA requires an IDE (Investigational Device Exemption) to be developed for any new product that is to be involved in clinical trials. This affects not just FDA Class III PMA devices, but increasingly many FDA Class II devices subject to 510(k) Premarket notification and clearance.

Areas Covered in the seminar:

  • The purpose of the IDE (Investigational Device Exemption).
  • Expectations of the FDA.
  • Its preparation -- recommended subject headings and content Submission and follow up Usage in the clinical trial(s) -- The IRB and "Informed Consent".
  • What you can and can’t do with product prototypes and their labeling Use in a follow-on 510(k).

Who will benefit:

  • Sr Management
  • R&D
  • Engineering
  • Marketing
  • QA / RA
  • Clinical trial administrators / monitors

Instructor Profile:
John E. Lincoln, consultant, has successfully designed, written and run all types of qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 27 years of experience, primarily in the medical device industry

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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 customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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