SESSION 3: risk management in medical devices
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. How can you do safety tests on your identified risks in the early stage of R&D, most easiest way, in a simple but controllable environment.
The following topics are covered in this session:
- 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
- Easy testing of identified risks in early R&D phase.
3.45 - 4 p.m.
Registration & coffee
4 - 4.10 p.m.
Introduction by TechMed Centre and Holland Innovative
4.10 - 4.20 p.m.
Status development pitches Q/A
4.20 - 4.50 p.m.
TechMed Talk: Clinical practice and risks - Ruud Verdaasdonk
4.50 - 5.45 p.m.
Workshop part 1: Introduction on risk management, intended use, safety and hazards, risk estimation and evaluation, risk control and residual risk evaluation.
5.45 - 6.15 p.m.
Meet & Eat: Sharing dinner
6.15 - 7.30 p.m.
Workshop part 2: Risk management, design controls, overall residual risk and management report, post design information
7.45 - 8 p.m.
Questions & wrap up
8 - 8.30 p.m.
Networking & drinks
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 & WHERE
- 10 December 2019
- 4 - 8.30 p.m. (registration from 3.45 p.m.)
- Entrance: € 30,- (incl VAT) per person
- Language: English
- Location: The TechMed Centre, University of Twente, Drienerlolaan 5; Route
The entrance for this session is € 30,- (incl. VAT) per person. If you want you can register for more sessions. Every other session will cost € 30,- (per session). We kindly ask you to pay before the start of the event.
We welcome a maximum number 50 participants. We will count on your participation for creating working groups and the catering. If you cannot attend the event for which you have already registered, we kindly ask that you let usknow. Simply e-mail email@example.com.
TECHMED SERIES: 8 UNIQUE SESSIONS
The TechMed Series "Remove the barriers to market readiness" is a one-year-course of workshops for (future) entrepreneurs and scientists in medical technology. The series covers the most important, but also most challenging topics required for the development and production of a safe, reliable and useful medical devices. Following the successes of the past years, we have updated the program to fit your needs on the road to market readiness. During the course of 1 year, 8 sessions are organized, taking place every month on an afternoon and focusing on one specific topic every session. During the sessions, you will work in groups to bring new knowledge to the test. There are no oblications, but we highly encourage you to bring your own case into the discussion! It is possible to attend the complete course, but also separate sessions.
ORGANIZATION & PARTNERS
This session is part of the TechMed Workshop Series ‘Remove the Barriers to Market Readiness’. The events are organized for (future) entrepreneurs in the medical device industry, take place every month on an afternoon and focus on one specific topic every session. By sharing their knowledge and expertise in the TechMed Series the partners aim to bring medical innovations 1 TRL level further and closer to a successful market introduction.