An Easy to Implement Integrated Risk Management Approach Compliant with ISO 14971

Instructor: Mercedes Massana
Product ID: 701773
  • Duration: 60 Min

recorded version

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

Training CD

One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556


Read Frequently Asked Questions

This integrated risk management training for medical devices will discuss how to incorporate risk management as per ISO 14971 guidelines in all phases of medical device development. It will highlight the documentation needed to support the decisions made as part of the risk management process.

Why Should You Attend:

ISO 14971 Medical devices - Application of risk management to medical devices is a voluntary standard that medical device manufacturers must incorporate into their design and development process in order to ensure medical devices designed are safe and effective. The FDA now also recognizes ISO14971, and can audit to it if manufacturer's claim they conform to it. Although ISO 14971 has been in place since 1998, many companies still find it difficult to properly interpret the requirements of the standards and having a risk management process which is not helpful in designing robust, safe medical devices.

This webinar will cover all major elements of ISO 14971 and present a methodology for integrating the requirements of this standard into the product development process to ensure that the requirements of the standard are met, and the medical device is designed to be safe and effective. The webinar will specify how risk management activities are incorporated in all phases of development, and what supporting documentation needs to be gathered in order to ensure that decisions made based on what is learned as part of the risk management process are adequately justified and documented.

Areas Covered in the Webinar:

  • How are risk management activities integrated throughout the development process.
  • The roles that Hazard Analysis, FTA, FMEA, HAZOP and PFMEA play in an Integrated Risk Management Process.
  • How to control and verify risk mitigations.
  • How to perform a Risk Benefit Analysis on ALARP and INTOLARABLE Hazards.
  • The importance of maintaing Risk Management documents in the Post Production era.
  • What information to include in the Risk Management Plan and Report for better auditability.

Who Will Benefit:

This webinar will provide a methodology that medical device companies can use in establishing a risk management process that is integrated with their product development process. The employees who will benefit include:
  • Systems engineers responsible for developing requirements
  • Software developers
  • Test Engineers
  • Quality System auditors
  • Engineering managers and personnel
  • Regulatory Affairs

Instructor Profile:

Mercedes Massana, is the founder and CEO of MDM Engineering Consultants, a consulting firm that provides engineering and quality consulting services in the medical device, biotechnology, and pharmaceutical industries. Mercedes has over twenty-five years of experience in the Medical Device industry. Extensive experience in developing processes within the constraints of FDA/lSO Quality Systems. She has been responsible for establishing processes and leading groups of engineering in the following disciplines: Risk Management, Requirements Management, Verification and Validation, Process Improvements, Project Management, Software Systems Validation, Process Validation. Mercedes is an ASQ certified Biomedical Auditor (CBA), Software Quality Engineer (CSQE), Quality Manager (CQMa) and Quality Auditor (CQA). Mercedes is well versed in FDA and ISO regulations.

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