Two Day Course: Risk Management in the Medical Devices Industry (Denver, United States - May 3rd-4th, 2018) - ResearchAndMarkets.com

DUBLIN--()--The "Risk Management in Medical Devices Industry" conference has been added to ResearchAndMarkets.com's offering.

Gaps, incorrect or incomplete implementation of software can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative.

This course will introduce all necessary steps to design, implement and test critical medical device software in a regulatory compliant environment. Software risk management has to be embedded into the bigger scope of overall risk management. Therefore this course will additionally address the system level risk management and the resulting interfaces to software.

To comprehensively summarize all risk related activities and to demonstrate the safe properties of a device, the 'Safety Case' or 'Assurance Case' document is a well-established method to collect all safety related information together in one place.

This documentation will most likely become mandatory for all devices (currently only required for FDA infusion pump submissions).

This course will introduce the basic concepts and content of safety assurance cases and will illustrate the usefulness for internal and external review of safety related information.

Who Should Attend:

  • Senior Quality Managers
  • Quality Professionals
  • Regulatory Professionals
  • Compliance Professionals
  • Project Managers
  • Design Engineers
  • Software Engineers
  • Process Owners
  • Quality Engineers
  • Quality Auditors
  • Medical Affairs
  • Legal Professionals

For more information about this conference visit https://www.researchandmarkets.com/research/3p5prn/two_day_course?w=4

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related Topics: Medical Devices

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related Topics: Medical Devices