Webinar date: 13 May 2015
Time: 4:00 (CEST) / 10:00 AM (EDT)
Presenters: Kristof Horvath & Peter Haller, Intland Software
What you can learn:
Developing medical devices is a complex process. Not only are these devices highly sophisticated tools that increasingly rely on embedded software ? they are also required to comply with stringent safety and reliability requirements. Rigorous industry standards (such as FDA CFR 21 Part 11, ISO 14971, IEC 62304) govern the quality of end products, as well as that of the processes involved in their development.
Risk management is a key process that helps ensure high product quality and reduce the chance of project overhead in terms of both time and costs. What's more, managing your risks can potentially save human lives, and mitigate the chances of device malfunctions that may lead to product recalls, financial losses due to lawsuits, and could also negatively impact your company's reputation.
In this webinar, we will show you how codeBeamer's advanced hazard analysis and risk management functionality, along with its Failure Mode and Effects Analysis (FMEA) template, supports compliance with relevant industry regulations.
1) Risks in medical device development
2) Risk Management Lifecycle
3) Failure Mode and Effects Analysis (FMEA)
4) Managing risks with codeBeamer
5) Compliance with industry standards
Our webinar is intended for:
Medical Device Developers, Software Developers and Architects, Quality Assurance Experts / Quality Engineers, Project Managers, Business Analysts
Webinar´s time (GMT +2:00) Brussels, Copenhagen, Madrid, Paris, South Africa
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