1st Edition  Conference

Risk Management in Medical Devices Industry

"Design and maintain devices efficiently"
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,Why Perform Risk Management?
  • International Regulatory / Statutory Requirements,Risk Management Lifecycle And Stakeholders
  • How To Implement Risk Management Into ISO13485,Software Unit And Integration Verification / Testing
  • Software Risk Management (IEC62304 / FDA Software Reviewers' Guidance),Real-Time System Challenges
  • Usability And Risk Management (IEC62366-1/-2 / FDA Human Factors Guidance),Usability Specification


8:30 AM - 4:30 PM (Sep 26) (General)
8:30 AM - 4:30 PM (Sep 27) (General)

Entry Fees

Paid Ticket Starts from 1899 USD View Details


20 Delegates
5 Exhibitors Estimated Count

Category & Type

Medical & Pharma
Education & Training


26-27 Sep 2019 Interested

Frequency Bi-annual

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Dallas L. Thomas, RAC, MHA, MPA

Dallas L. Thomas, RAC, MHA, MPA

Regulatory Affairs and Quality Auditing Consultant for Medical Device at Thomas Regulatory Resolutions, Inc. Orlando, United States

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1899 USDAttendee Seminar One Registration
27.951000 -82.457000

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Tampa, USA

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