Risk management: how to ensure safety of a medical device and comply with ISO-14971?
Techmed workshop series 3/6
The use of a medical device entails some degree of risk to the patient, but also to the operator, other persons, other equipment or the environment. The process of risk management identifies, evaluates and eliminates or reduces the risks. The standard ISO-14971:2012 is the guidance. It is mandatory to follow this standard, when applying for CE certification.
WHAT In this workshop the following activities will be handled:
1) Define intended use
2) Identification of characteristics related to safety.
3) Identification of hazards on for example electrical safety, biocompatibility or user errors.
4) Estimation and evaluation of risks.
5) Risk control: measures to eliminate/reduce risk.
6) Residual risk evaluation.
7) Risk benefit analysis.
8) Analysis of production and post-production information.
9) Documenting risk management in the Design History File.
FOR WHOM If you are responsible for the development and design of a safe medical device and want to know how to identify and manage the safety risks, this work shop will learn you which tools you need to use and which results you need to deliver in order to comply with the ISO-14971 Risk Management standard.
WHEN Thursday 9 November 2017, 16:00-20:00
WHERE Oosthorst 210, University of Twente, Enschede
Registration & Coffee
Introduction on Risk Management
Intended use, Safety and Hazards
Risk Estimation and Evaluation
Risk Control and Residual Risk Evaluation
Risk Management & Design Controls
Overall Residual Risk, Management Report,
Questions & drinks
It is a workshop, so cases are included.
This workshop is part of the TechMed Workshop Series ‘Remove the Barriers to Market Readiness’. This one-year-course of workshops covers the most important, but also most challenging, topics required for the development and production of a safe, reliable and useful medical device. The workshops are organized for (future) entrepreneurs in the medical device industry, take place every 2 months on an afternoon and focus on one specific topic every session. It is possible to attend the complete course, but also separate workshops.
The TechMed Workhsop Series is part of the TechMed Proeftuin. By sharing their knowledge and expertise in the workshops series the TechMed Proeftuin partners aim to bring medical innovations 1 TRL level further and closer to a successful market introduction. The TechMed Proeftuin receives funding from the European Regional Development Fund (ERDF) of the European Union; the Workshop Series can therefore be offered free of charge.
This workshop is powered by Proeftuin partner(s):