About the course Fundamentals in Medical Device Development
The development process starts with an idea and ends with a medical device that is safe, suitable for its intended purpose and is, most of all, CE certified (by a notified body). This newly developed course provides insights into the different roles involved within the product development process. The course will show how the expertises Regulatory, Design for Six Sigma and Project Management cooperate as a team to successfully complete the design of the medical device. It creates a better understanding and internal synergy for an improved flow and market introduction.
Subjects of the course Fundamentals in Medical Device Development
During the Fundamentals in Medical Device Development course the following subjects will be discussed:
- Project Management for medical device development
- Project timeline showing the correlation of all project competences, activities and deliverables
- Steps in CE certification according to the MDR, using applicable harmonized standards
- Safety Risk Management, Usability Engineering and Clinical Evaluation
- Quality Management System based on ISO 13485
- Design for Six Sigma for medical device development
- Market CTQs (user needs), internal CTQs, measurement system analysis and reliability tools
- Verification, validation and appropriate statistical analyses
- Personal leadership, communication and behaviour
Results of the course Fundamentals in Medical Device Development
During the Fundamentals in Medical Device Development course you will learn:
- To understand the project management framework and besides design controls & risk management
- Get enthusiastic involvement of engineers, architects, and managers in order to comply with the medical device regulations and to execute projects effectively and completely
- To define and understand customer needs coupled with critical device requirements
The Fundamentals in Medical Device Development course is designed for managers and engineers who are tasked with managing and executing medical device projects, project teams and regulatory/engineering activities.
The course Fundamentals in Medical Device Development consists of 3 blocks of one day each, from 9 am to 5 pm.
Location, dates, & schedule
This training is offered in our 1.5-meter classrooms, online or hybrid. Moreover, we have both in-company as free enrollment possibilities.
Location: Enschede – The Building, Hengelosestraat 500
Location: Eindhoven – High Tech Campus 29
Day 1: October 19
Day 2: October 26
Day 3: November 2
The investment is € 2.550,- (excl. VAT) per participant. Included are three training days, course material, tools and templates, lunches and beverages.
The course will be given by qualified professionals who will assist you in the following areas of knowledge:
• Project Management:
Working as a Projectmanager at Holland Innovative, Wim has over 25 years of experience with successful project management (more complex than PRINCE2, IPMA) translating strategy and policy to concrete targets, projects and processes and has executed them.
• Design for Six Sigma & Reliability::
Theo de Goede
Passionate Master Black in the field of customer-focussed design in the High/Med-Tech field. At Holland Innovative, his knowledge is directed to the Design for Six Sigma and Reliability Engineering area.
Seasoned Six Sigma expert supporting improving designs and processes Working as Product & Process Specialist at Holland Innovative.
Experienced Project Manager with a demonstrated history of working in the medical device industry. Project management professional and Regulatory specialist skilled in managing the development of (software) products with a strong affinity for Quality assurance and Regulatory affairs.
Lisette van Steinvoren
Projectmanager with several years of experience in –medical device- product development within both multinationals & SME’s, Lisette has a background in Applied Physics & Innovation Management from the University of Utrecht. She is Six Sigma Black Belt and IPMA-C certified. Working as Sr. Project Manager Medical at Holland Innovative
Certificate / diploma
Participants who have followed the full training receive a certificate of participation.
Method of teaching
The course is offered as an in-class course, but any other form is open for negotiation. We are able to offer offline, online and hybrid courses. Besides that, there is, either way, plenty of opportunities to do exercises in both workgroups as individuals.
Asking questions, remarks and other interactive moments are encouraged.
A maximum of 10 participants
After the training, holland-innovative optionally offers on-the job coaching to further improve and implement the medical device development process and practices in your company.
This course can also be given specifically within your company.