The workshop
Risk Management: How to ensure safety of a medical device and comply with ISO-14971?
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.
In this workshop the following activities will be handled:
- Define intended use
- Identification of characteristics related to safety.
- Identification of hazards on electrical safety, biocompatibility or user errors.
- Estimation and evaluation of risks.
- Risk control: measures to eliminate/reduce risk.
- Residual risk evaluation.
- Risk benefit analysis.
- Analysis of production and post-production information.
- Documenting risk management in the Design History File.
DETAILED OVERVIEW
16:00 - 16:15 | Registraton and coffee |
16:15 - 16:30 | Introduction on Risk Management |
16:30 - 17:00 | Intended use, Safety and Hazards |
17:00 - 17:30 | Risk estimation and Evaluation |
17:30 - 18:00 | Risk control and Residual risk evaluation |
18:00 - 18:45 | Food |
18:45 - 19:15 | Risk management and Design controls |
19:15 - 19:30 | Overall Residual risk and Management report |
19:30 - 19:45 | Post design information |
19:45 - 20:00 | Questions, networking and drinks |
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.
Where & When
- 4 December 2018
- 16:00-20:00
- Carré 3.022, Auditorium ECTM
- University of Twente, Drienerlolaan 5, Enschede
speaker
New products need to be as reliable as possible, have the potential to the market quickly, and, above all, they need to meet the expectations and requirements of the customer.
Holland Innovative is specialised in Project Management, Product an Process Development and Reliability Engineering. Customers include leading multinationals, Small and Medium Enterprises (SME's) and start-ups. They have a strong desire to do things differently - in a better way.
Holland Innovative delivers excellence, experience, the power of implementation and, above all, flexible project managers and experts.
REGISTRATION
We welcome a maximum number of 50 participants. Participation is free of charge. We will count on your participation for creating working groups and catering. If you cannot attend the event for which you have already registered, we kindly ask that you let us know. Simply e-mail techmed-events@utwente.nl.
ORganization: TECHMED WORKSHOP SERIES
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.
