ISO 14971:2007 and the CE-Mark

Instructor: John E Lincoln
Product ID: 701597
Training Level: Intermediate to Advanced
  • Duration: 88 Min

recorded version

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Last Recorded Date: Apr-2010

Training CD / USB Drive

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Read Frequently Asked Questions

This ISO 14971:2007and CE-Mark training will help in understanding the elements of your product risk management file and how to comply with ISO 14971 or ICH Q9.

Why Should You Attend:
Both the U.S. FDA and the EU's MDD require companies to be proactive in reducing product risk while increasing user benefits. One of the best tools to achieve and document this is ISO 14971. Many firms use some product risk management tools, but are not compliant to ISO 14971, or the U.S. equivalent ICH Q9.

Attend the Webinar to understand the elements expected to be in the Risk Management File. The Report. Learn how to blend ISO 14971 and ICH Q9. Make the document a "living" document. Achieve major business benefits by regular use of the Risk Management File / Report in training, marketing, validation, root cause analysis, CAPA activities and failure investigations, as well as the obvious, reduced liability.

Additionally this Webinar will enable you to understand what changes would be necessary to become compliant? What are Europe and U.S. regulatory expectations? What benefits beside regulatory compliance can be achieved for a company?

Areas Covered in the Seminar:

  • Key requirements of ISO 14971; ICH Q9.
  • Suggested formats.
  • Expected sources of information to evaluate.
  • What to include.
  • How to complete, document, and control.
  • An often neglected safety feature.
  • A "living" useful, cost-saving document.

Who Will Benefit:

This webinar will provide valuable assistance to personnel in all regulated companies responsible for cGMP and MDD/CE-mark compliance. This information applies to primarily to personnel / companies in the Medical Device industry. However, its principles apply and can be used in other regulated industries, e.g., pharmaceutical, Diagnostic, Biologics and Dietary Supplements. The employees who will benefit include:
  • Senior management
  • Regulatory Affairs
  • Quality Assurance
  • Production
  • Engineering
  • Sales and Marketing
  • All personnel involved in a U.S. FDA- and/or EU ISO 13485/MDD-regulated environment

Instructor Profile:
John E. Lincoln, is Principal of J. E. Lincoln and Associates, a consulting company with over 28 years experience in U.S. FDA-regulated industries. John has worked with companies from start-up o Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).

In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. John is a graduate of UCLA.

Follow us :
Critical Vendor Risk Management
Medical Device Summit 2018

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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