As a member of a medical device development project team you have to cope with a wide variety of elements in the project or program within your organization (e.g. your medical device company or a healthcare provider). The development process is a journey that starts with an idea and ends with a medical device that is safe, suitable for the intended use, and CE certified (by a notified body). This course Fundamentals in Medical Product Development will illuminate the development process and show you how to use the roadmap of design controls, regulatory, Design for Six Sigma and project management to successfully complete the development process.
New products, processes and systems need to be developed faster and with increasing quality, safety and reliability levels. Specifically in the medical device industry, regulations and quality management systems are a key elements for success. Design flaws, rework, wasted time, warranty claims, or even brand image loss need to be prevented. Learn how to execute and facilitate a medical device development project by using design and development plans, design reviews, risk analysis, FMEA, etc., as an integral and effective part of your product
development process. Get enthusiastic involvement of engineers, architects, and managers in order to comply with the medical device regulations and to execute projects effectively and completely. But all of that is only valuable if you start identifying the right customer needs based on quantitative and qualitative data gathered by interviewing and observing the customer. In this course you will experience how to define and understand customer needs coupled with critical device requirements.
Program Fundamentals Medical Product Development
Day 1 Understanding the project management frame work. Design controls & risk management.
Day 2 Regulatory, standards, QMS.
Day 3 Design for Six Sigma (market CTQs, internal CTQs, MSA, reliability.
Day 4 Project management in medical product development
• Project Management:
Sr. Project Manager Medical Lisette van Steinvoren and Sr. Project Manager Wim Schouten
• Design for Six Sigma:
MBB Product & Process Professional Theo de Goede and Sr. Product & Process Specialist Ton Meek
Theo de Goede and Ton Meek
Sr. Project Manager Medical Jolande Koobs and Lisette van Steinvoren
Do you have a question about one of our courses?
Would you like to discuss the possibilities? Please contact us for further information.
T: +31 (0)40 851 4611
Course duration and number of participants:
Four modules of one day each from 9 am to 5 pm. Maximum group size: 10 participants. This course can also be given specifically within your company.
Location and costs:
Utrecht/Amsterdam/Eindhoven. The costs are € 2.950,- (excl. VAT) per participant. Included are four training days, course material, tools, lunches and beverages.
Spring: Utrecht/Amsterdam area – dates & location to be defined
Autumn: Eindhoven area – dates & location to be defined