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3rd European Workshop on Medical Device Safety











 Warwick Clinical Systems Improvement


3rd European Workshop on Safety of Programmable Electrical Medical Systems:

"Assurance Cases for Medical Devices"




Thursday 25th September 2008, 9:00 - 17:00

Newcastle University

In conjunction with

the 27th International Conference on Computer Safety, Reliability & Security SAFECOMP 2008 


EWICS TC7 Medical Devices Subgroup and Warwick Clinical Systems Improvement invite contributions and participation in this 3rd European Workshop on Safety of Programmable Electrical Medical Systems: "Assurance Cases for Medical Devices".

In 2000 and 2003, EWICS TC7 Medical Devices Subgroup organised Workshops on Safety of Programmable Electrical Medical Systems (PEMS) with participants from industry, standardisation bodies, regulators, research and end users to discuss emerging safety and risk management issues related to medical devices with programmable components. These workshops aimed to identify areas of concern regarding the safety of programmable medical systems in operational use, which are not yet adequately addressed in standards, other regulation or guidelines.

At the 1st Workshop in Gatwick, the main focus was on software systems and risk management. The 2nd Workshop in Edinburgh was focussed on human factors, networked systems and system integration. Main standards on Medical Devices, such as the IEC 60601 series on safety, ISO 14971 on Risk Management, and more recently also IEC 62304 on software do not cover safety of networked medical systems that consist of medical devices that are linked together.

Since these workshops, the identified problem areas of system integration, networked systems, usability, risk management by user organisations, and software modification management have received more attention in standards work (e.g. new work on IEC 80001) as well as in the revised EU Medical Device Directive (2007), but problem areas such as multi-vendor networked medical devices regarding system integration and complexity management, as well as management of software systems by user organisations remain open challenges. Furthermore, the interest in the safety case approach in the medical field is increasing rapidly, and for good reasons as it potentially enables to bring safety assurance objectives and evidenced proofing arguments together from different stakeholder perspectives.

With this 3rd Workshop we will focus in particular on Assurance Cases for Medical Devices, and their potential to address problem areas such as facilitation of communication between different stakeholders, the integration of evidence from different manufacturers in multi-vendor systems, and the integration of devices by the healthcare service provider (the end user).

Aims & Format

The aim of the workshop is to:

  • Exchange information about state-of-the-art topics related to medical device safety, in particular assurance cases and networked medical devices
  • Identify and discuss open and problematic topics including different views in the EU and US
  • Identify new areas of interest for work within the EWICS Medical Devices sub-group (guidelines, pre-standardisation activities)

The workshop intends to be an active forum for discussion between individuals from diverse backgrounds with an interest in the topic. Hence, the workshop is organised into four sessions:

  • Session 1: Short presentations
  • Session 2: Group discussions in break-out sessions
  • Session 3: Plenary presentation and discussion of the conclusions drawn during the group sessions
  • Session 4: Conclusions, recommendations for EWICS Medical Devices sub-group, wrap-up


We invite submission of one-page abstracts (A4) related to Assurance Cases for Medical Devices. Topics of interest include:

  • Pre- and post-market risk management of Medical Devices
  • Development and management of Assurance Cases for networked Medical Devices
  • Multi-vendor Assurance Cases
  • Assurance Cases in home care settings
  • Standardisation, Regulation and Assurance Cases
  • Views on the role of the end user / service provider
  • Building the capability for systematic risk management in healthcare organisations

Abstracts should be received by July 31st, 2008. Please email your contribution to Floor Koornneef and Mark Sujan.


After the event, we will invite some of the presenters and participants to contribute chapters to an edited book on the workshop topic.

Participation & Registration

In order to ensure an active discussion with diverse views, there should be a good mix of participants from different stakeholder areas such as device manufacturers, members of standardisation bodies, regulators, users of medical devices, individuals responsible for patient safety and risk management, and members of health authorities. Participation is limited to 40 delegates. To express an interest in participation, please email Floor Koornneef and Mark Sujan indicating your professional background and your interest in the topic. Confirmation to both presenters and participants will be sent in August.

Registration fee is £35 and includes coffee breaks and lunch. After participation has been confirmed, please download and print the registration form from the Safecomp 2008 website and follow the instructions there.


For general information about EWICS TC7, please see or contact Udo Voges.