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

Duration: 75 Minutes
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 other related processes (CAPA, Complaint Management, Non-Conformances), 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.
Instructor: Mercedes Massana
Product ID: 501072
Objectives of the Presentation
  • 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
  • The importance of maintaining Risk Management documents in the Post Production era
  • What information to include in the Risk Management Plan and Report for better auditability
  • How to integrate Risk Management with CAPA, Complaints and Non-Conformance processes
Why Should you Attend
ISO 14971 Medical devices - Application of risk management to medical devices is a voluntary standard that medical device manufacturers should 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.

Who can 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:
  • Risk Managers
  • Systems engineers responsible for developing requirements
  • Software Developers
  • Test Engineers
  • Quality System auditors
  • Engineering Managers and Personnel
  • Regulatory Affairs
$375
Recorded Session for one participant
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Live Session - How it works
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  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
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 thirty 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: Systems Engineering, 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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