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Techmed workshop series (5/6) - Design verification Desgin verifcation and validation

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THE WORKSHOP

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.

COURSE AIM

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

 

DETAILED OVERVIEW

16:00 - 16:15

Registration and coffee

16:15 - 16:30

Introduction verification & validation

16:30 - 17:00

Design verification

17:00 - 17:30

Design validation

17:30 - 18:00

Process: Installation qualification & Operation qualitive (IQ & OQ)

18.00 - 18.45

Food

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

FOR WHOM

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
  • 16:00-20:00
  • Carré 3.022, Auditorium ECTM
  • University of Twente, Drienerlolaan 5, Enschede

 SPEAKER

HOLLAND INNOVATIVE
LISETTE VAN STEINVOREN
Sr. Project Manager

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 and 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.