1st Edition  Conference

Applying ISO14971 IEC62304 IEC62366-1 a Practical Guide on How to Implement Risk Management

"Develop a risk analysis framework document"
Risk management is a mandatory and necessary process during the entire device life. Not only will it help to design and maintain devices efficiently, but it also ensures that the device will be as safe as possible and prevents harms to patients, users, and the environment.Like any process that tries to produce repeatable and consistent results, the risk management process must be clearly understood, including the strengths but also the limitations.By attending this seminar you will learn the main elements of ISO 14971, ISO 13485, IEC62304, IEC62366-1/-2, risk management life cycle steps and benefits, and FDA software reviewers' guidance.


  • Introduction To Risk Management And Quality System Integration,Risk Management To ISO 14971:2012
  • How To Implement Risk Management Into ISO13485,Software And Usability In Risk Management
  • Risk Management Report and Documentation,Software Risk Management ,Software Risk Management
  • FDA Part 11 Requirements o Document Integrity,Device Architectures And Mitigation Allocation
  • Qualification of Manufacturing / QMS software,Assurance Case Vs. Risk Management Report


8:30 AM - 4:30 PM (Nov 04) (General)
8:30 AM - 4:30 PM (Nov 05) (General)
8:30 AM - 4:30 PM ( Nov 06) (General)
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Entry Fees

Paid Ticket Starts from 2299 USD View Details


20 Delegates
5 Exhibitors Estimated Count

Category & Type

Medical & Pharma
Education & Training


04-06 Nov 2019 Interested

Frequency Bi-annual

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Michael Newton Gambo

Michael Newton Gambo

Regulatory Officer/Molecular biologist at Food and Drugs Authority Accra, Ghana

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2299 USDAttendee Seminar One Registration (USD)
47.377000 8.542000

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Zürich, Switzerland

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