Design verification and validation.
Verification and validation are 2 essential steps in the development process of a medical device. On behalf of the inspection of the CE of your medical device, you have to be able to apply verification and validation. By means of verification and validation you show that your product and production process meet the requirements and are suitable for the intended use.
During this workshop you will learn more about the background, but also about practical issues. Your own cases will be used for hands-on practice during the workshop.
Main points discussed are:
- Which steps should be taken during design verification and design validation?
- When to apply process verification and when to apply process validation
- What is meant by the terms Installation qualification”, “Operation Qualification” and “Performance Qualification”. Also known as IQ, OQ and PQ
16:00 - 16:15
Registration and coffee
16:15 - 16:30
Introduction verification & validation
16:30 - 17:00
17:00 - 17:30
17:30 - 18:00
Process: Installation qualification & Operation qualitive (IQ & OQ)
18.00 - 18.45
18.45 - 19.15
Performance Qualification / Process Validation (PQ)
19.15 - 19.45
Proces Verification: 100% inspection
19.45 - 20.00
Questions, networking and drinks
This workshop is relevant for everyone who is working on a medical device (prototype/product), such as engineers, project managers and quality managers.
WHERE & WHEN
- 14 February 2019
- Carré 3.022, Auditorium ECTM
- University of Twente, Drienerlolaan 5, Enschede
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 firstname.lastname@example.org.
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.