sitem Center for Translational Medicine and Biomedical Entrepreneurship

Standalone Modules

Module 6 - Risk Management and Usability Engineering

 

Content

Module 6 teaches the purpose, methodology and regulation of medical device risk identification, assessment and mitigation. The module includes a comprehensive study of usability regulation, assessment and risk assessment.

Learning objectives

Upon successful completion of this module, participants understand risk management and risk-based approach within the lifecycle of a medical device, the requirements of the risk management process, know how to perform risk management activities and write risk management documents and are aware of the usability principles and know how to analyse usability risks.

Learning content

This module includes the standards for risk management in medical devices, risk based approach  - parallel with ISO 13485 and Medical Device Regulation -, risk management planning, risk management in the design phases, hazard identification, establishing severity, probability and the risk matrix and risk control measures - how can we reduce risk? It furthermore covers technqiues for risk analyses and risk manage-ment for production processes, risk management in post-market phases, including change management, and usability engineering standards for medical devices and designing usability engineering studies.

Start & Duration

2020: 4 January 2021
2021: TBC

The completion of this module takes approximately 13 weeks.

Credits

5 ECTS

Fee

The cost of this standalone module is 5250.– SFr.

Reference

03.006

 

Module Leaders

Competence Cluster Lead & Senior Consultant, confinis ag

Stefano Adami

Stefano Adami, Senior Consultant and Competence Cluster Lead at confinis ag, holds a BSc in mechanical engineering and a master in sustainable management and has 15+ years of experience in medical devices development, manufacturing, quality management, and regulatory affairs. Within confinis he consults from start-up to global medical device companies for compliance in quality and regulatory, some of them getting their first product to the market thanks to confinis team. 

Medtech Senior Specialist

Andrea Schütz Frikart

Andrea Schütz Frikart is a senior expert with 20 years experience in medical device development as a former development project leader at Roche Diabetes Care, as an inspector at swissmedic, the national competent authority and as a Senior Consultant to support international clients in the field of medical device and combination products as well as a lecturer for various institutes in Switzerland. She specializes in regulatory affairs, usability engineering and design control.