Inspections Summit Preview - Webinar CD/Transcript

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Inspections Summit Preview: Recertification Audits - Don’t Let Your Devices Lose Their CE Mark

Having your facility certified to produce medical devices for sale in Europe is only the first step. Regulations newly in force say your Notified Body must audit you at least once every three years, and these audits will focus less on the facility and more on the devices themselves. These audits are unannounced and, depending on your size, could take anywhere from a few days to several weeks. If you fail one, you’ll be at risk of having your devices lose their CE mark, meaning you’ll be barred from selling them in the EU until the problem is corrected.

Do you know…

  • Who TÜV, DEKRA and BSI are and why you should be working with one of them?
  • Whether each of your devices is classified as I, IIA, IIB, or III?
  • Which classes will require a design dossier or a technical file?
  • The difference between horizontal and vertical standards?
  • Which of those standards apply to each of your devices, and the last time they were updated?
  • The specific kinds of objective evidence auditors will expect to see?
  • What factors could lead to more frequent audits?

If you can’t give a confident “yes!” to every one of those questions, Roberta Goode’s webinar will provide the answers you need. Don’t risk having costly obstacles come between your devices and the European market.

  • Auditors
  • Compliance officers
  • Engineering and design controls teams
  • Executive management
  • General/corporate counsel
  • Investigators
  • Managers
  • Manufacturing directors and supervisors
  • QA/QC personnel
  • R&D staff
  • Regulatory/legislative affairs professionals
  • Risk management specialists
  • Training personnel
  • Validation specialists, scientists, engineers

Roberta Goode
President and CEO, Goode Compliance International

Roberta Goode is an executive with over 25 years of experience in the medical device industry. She is currently President and CEO of Goode Compliance International (GCI), a global leader in engineering and compliance services for medical device manufacturers, specializing in process validation, design control, and risk management. Prior to founding GCI in 2002, Ms. Goode held positions of increasing responsibility in R&D, Manufacturing, and Quality Engineering at Beckman-Coulter Corporation, Althin Medical, Inc. (acquired by Baxter Healthcare), and Cordis Corporation (a Johnson & Johnson company), where she contributed intellectual property in the form of four U.S. patents for percutaneous cardiovascular interventional devices. She holds a Master of Science degree in Biomedical Engineering and a Bachelor of Science degree from the University of Miami. Additionally, Ms. Goode has an adjunct faculty appointment at the University of Miami’s College of Engineering and is an ASQ Certified Quality Engineer.