3 Informative webinars on ISO 14971 and Risk Management for Devices

ISO 14971 is an international risk management standard for medical devices. It is widely recognized as the official standard for medical device risk management. ISO 14971 applies to all medical device manufacturers and all medical devices and should be used to manage risk throughout all stages of the product life-cycle from initial concept right through to final disposal.
Instructor: Ron Schoengold, Peter Spath, David Amor
Product ID: PACK70018

This course pack explains the application of Risk Management for medical devices using ISO 14971. It explains the information flow from the Risk Management Plan to the Risk Management Report.

CD/Recorded-How It Works:

  • Webinar CD/Recorded will have a series of modules. Our experts have delivered the modules using PowerPoint Presentations.
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  • Recording links will be valid up to 6 months with unlimited access and reference materials will be mailed to your registered e-mail.
  • Free shipment of CDs within 72 hours from the date of purchase and reference materials will be mailed to your registered address.

Webinar Topics:

Who will benefit?

These webinar will be beneficial to the following:

Engineers | Management | Directors | VPs | Marketing managers, supervisors & personnel | Internal Auditors | Senior management executives (CEO, COO, CFO, etc.) | Project Managers | Quality Managers | Regulatory Managers | Program Managers | Project Managers | Product Development Managers | R & D Managers

Webinars included in the Package:

Understanding ISO 14971:2012: Changes to Annex Z and Impact on the Risk Management File (Duration: 60 Minutes)

ISO 14971 has long been the gold standard of risk management for medical device companies. Recently, several changes to Annex Z have been implemented in the 2012 revision which otherwise may go unnoticed but which have significant impact to the risk management file. Learn about the discontinued support of the ALARP principle and how to address negligible risks, new requirements surrounding risk benefit analyses and mitigation strategies for risks that don’t include labeling. This discussion will use case studies to create a practical approach to modifying or creating your risk management file.

Objectives of the Presentation:

  • Highlight key changes to ISO 14971:2012
  • Review Annex Z change impact to current risk management strategies
  • Learn how to update your risk management file to comply
  • Review case studies of real examples

Instructor Profile:

David Amor is a medical device consultant, having worked with companies such as Boston Scientific, St. Jude Medical and Hospira in helping develop quality management systems and product development infrastructures. A graduate of the Senior Innovation Fellows program at the University of Minnesota Medical Device Center, David was named a Top 40 Under 40 Medical Device Innovator in 2012 and founded MEDgineering, a niche quality consulting firm focusing on FDA remediation and remote work solutions.

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Post Approval Risk Management Strategy (Duration: 60 Minutes)

We will discuss how Risk Management Files are developed and maintained in accordance with ISO 14971 throughout the product lifecycle. Organizations wishing to market Medical Devices in Europe must develop Quality Management Systems in accordance with ISO 13485 and ISO 14971. ISO 13485 requires proof of Risk Management use and FDA expects it. We no longer refer it as Risk Assessment because that is only a small part of what is required. Risk Management activities start at concept design with the development of the Risk Management File. This file provides information on the original risk analysis, risk evaluation, and control measures established at the time of design release to manufacturing. Any product changes, including labeling, must be evaluated in accordance with your Risk Management procedures.

Objectives of the Presentation:

  • Overview of ISO 14971 Medical devices - Application of risk management to medical devices
  • Discussion of key requirements
  • What written procedures and training are required
  • How to develop Risk Management Files
  • How to apply Risk Management to Post-Approval Labeling Risk Management Strategy
  • Understanding of what auditors expect

Instructor Profile:

Peter Spath is currently a freelance consultant serving the Medical Device community by providing a variety of quality and regulatory consultation on contractual basis remotely and on-site. Services include: leading Quality System audits in accordance with ISO 9001, 17025, and 13485, Canada's CMDCAS regulations and FDA GMPs for both Medical Devices and Combination Devices. He has over 20 years of experience working with international regulations and standards as a Certified Lead Auditor.

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Risk Management for Medical Devices: ISO 14971:2007 (Duration: 60 Minutes)

The company is required to implement a risk management program as an integral part of its quality system. A robust risk management program identifies and manages hazards throughout the product lifecycle. Once identified, hazards must be eliminated or mitigated to achieve the highest possible level of product safety and effectiveness. The company depends on its risk management program to continuously monitor and evaluate potential hazards associated with its products, and to take appropriate actions designed to lower the probability of harm to stakeholders.

Objectives of the Presentation:

  • Understand how to manage risk to promote product safety and effectiveness
  • Comply with current standards and regulations
  • Make better project management decisions
  • Provide exposure to basic risk modeling tools
  • Promote customer confidence

Instructor Profile:

Ronald Schoengold has been an active contributor to the medical device, pharmaceutical and biomedical environment for over 45 years. As a consultant to both large and small companies, he offers expert advice on quality systems, regulatory submissions and resolution of regulatory and quality problems. He is also an experienced auditor in clinical research, supply chain and manufacturing (CGMPs).

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