Subject: FDAnews Announces — 1 Week Left to Register for Medical Device Risk Management: Understanding the Regulatory Landscape Nov. 6-7, Newton, MA (Boston)

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Risk management international standards are under revision. Come to terms with risk management now. Here’s how…

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Medical Device Risk Management
Understanding the Regulatory Landscape
**An interactive workshop from FDAnews and Ombu Enterprises**
Nov. 6-7, 2019 • Newton, MA (Boston)
https://www.fdanews.com/mdriskmanagement

One week left to register for Medical Device Risk Management: Prepare for the Winds of Change.

Risk management is just plain hard — complicated, conflicted, confusing. And it’s getting harder.

ISO 14971 is being revised. While the changes aren’t intended as “major," the new standard adds new definitions… changes the clause numbering… introduces new requirements… changes many of the annexes, and moves them to a new document.

And at the same time the EU is in transition to new regulations. There are new concepts… new risk reduction requirements… and new applications. Two areas of impact are side effects (residual risk) and benefit-risk analysis as a life-cycle requirement.

Risk management procedures will require a major overhaul.

FDAnews and Ombu Enterprises are here to help attendees prepare with a two-day workshop designed to untangle every mystery of risk management and put attendees on a path to full compliance. During the workshop attendees will:

  • Understand the regulatory structure including the US, Canada, the EU current state, and the EU future state
  • Review recent FDA warning letters and understand how to avoid problems
  • Learn the process flow in the new standard, ISO 14971:2019
  • Understand the details of the EU variant, EN ISO 14971:xxxx
  • Understand the risk management changes arising from the EU-MDR and EU-IVDR
  • Review the risk management audit tasks from the MDSAP Audit Model
  • Understand the role of risk management in post-market surveillance

The risk management guide is Dan O’Leary, a favorite presenter at dozens of FDAnews-sponsored workshops. Dan provides the understanding and practical tools to join the disparate pieces into a coherent whole and create a solid foundation for the coming changes. Dan boasts more than 30 years’ experience in quality, operations and program management in regulated industries including aviation, defense, medical devices and clinical labs.

Risk management affects nearly every aspect of medical device manufacture. Yet many devicemakers lag behind the curve, courting warning letters or worse. Get operations up to speed quickly and easily.

Reminder: Medical Device Risk Management: Prepare for the Winds of Change starts in one week.

Webinar Details:
Medical Device Risk Management
Understanding the Regulatory Landscape
**An interactive workshop from FDAnews and Ombu Enterprises**
Nov. 6-7, 2019 • Newton, MA (Boston)
https://www.fdanews.com/mdriskmanagement

Tuition:
Regular Pricing: $1,797
Significant team discounts are available.

Easy Ways to Register:
Online: https://www.fdanews.com/mdriskmanagement
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and
business news and information for executives in industries regulated by the US FDA and the
European Medicines Agency. Pharmaceutical and medical device professionals rely on
FDAnews' print and electronic newsletters, books and conferences to stay in compliance
with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDAnews
703-538-7600
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