Risk management for medical device software according to ISO 14971

Medical device software (stand-alone, mobile medical apps, web applications) or software that is integrated into medical devices (firmware, embedded software) must be designed in such a way that reliability and performance are ensured according to their intended use. In doing so, and in accordance with the EU regulations MDR/IVDR, risks must be eliminated or minimized as far as possible without adversely affecting the benefit-risk ratio.

The establishment of an interactive risk management process throughout the product lifecycle is essential for every manufacturer of medical devices. It is important to take legal requirements and applicable standards into account. Specifically for medical device software, additional requirements apply, such as the impact of software errors, negative interactions, aspects of the IT environment and IT security, as well as safety-critical functions. The overall risk assessment in the context of verification and validation steps presents significant challenges for manufacturers of medical device software.

In this in-house seminar, participants will learn the fundamental requirements for risk analysis of medical software according to applicable standards. They will be able to conduct a risk analysis and properly document the results. Furthermore, they will be able to assess risks in their software and, on this basis, prepare a risk management report.

The seminar contents

  • Fundamentals of risk management, definition of terms
  • Risk management process and ISO 14971
  • Risk management analysis, documentation requirements
  • Risk analyses for software (scenario-based risk analysis, software architecture, root-cause analyses, FTA, FMEA, third-party components, concepts of IEC/TR 80002-1)
  • Risk assessment and risk management report
  • Production and post-production activities (configuration management, deployment, updates of databases, operating systems, etc.)
  • Change management and risk
  • Normative requirements (EN ISO 14971:2019/A11:2021, guidance from ISO/TR 24971 and IEC/TR 80002-1:2009, etc.)

Costs

1 day in-house training: € 3,890 (excl. VAT) for max. 10 participants
incl. seminar documents and certificate of attendance, plus travel expenses

your trainer

DI Martin Schmid, Managing Director & Senior Consultant en.co.tec
Information about our trainers

Book now:

Please send your request to seminare@encotec.at or call us: +43 1 8863491 +43 1 8863491