PROJECT MANAGEMENT FOR PRODUCT DEVELOPMENT OF MEDICAL DEVICESPUBLIC COURSE / IN-HOUSE COURSE
This 4-day course provides a high level overview for developing a medical device as well as the tools and techniques for project delivery.
The course has an integrated approach to project management and is suitable for a range of different job roles within the medical device sector. Topics include:
- How to define requirements
- Which requirements must be met to CE mark a product
- Where risk analysis and usability should be introduced into a product development project.
All the subject matter of the Design Control course is also included within this course.
Due to the current COVID-19 situation, we are continuously evaluating when and how we can safely run classroom courses. If you are interested in attending a classroom course, please register you interest by filling out the form below.
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Peter Sebelius is a highly esteemed trainer, consultant and entrepreneur in the medical device industry. He is a member of the Joint Working Group that is revising the ISO 13485 and ISO 14971 standards.
He has vast ‘hands on’ experience, having developed, amongst other things, a mechanical chest compression device and an ex vivo perfusion machine for lungs. He has received numerous awards including the Great Design Award and the title “This year’s specialist” by Veckans affärer.
Benefits for you
Know how to develop a medical device from beginning to end
This course will guide you through the process from invention or market brief, through pre-studies, to product approval and everything in between, preparing you to lead or take part in that process.
Know the pitfalls of medical device development and how to avoid them
We don’t live in a perfect world. This course talks about pitfalls, challenges and issues that many medical device projects face, and not least, how to avoid them. This will prepare you and make you ready to combat a lot of difficult situations in your work-life.
How to avoid missing project deadlines
A challenging part for many is how to ensure a project finishes on time. The course has a comprehensive lesson on scheduling and how to avoid schedule slippage and the embarrassment of not delivering on time.
95% says it is the best course they have ever taken
This course is spot on for project managers and consultants wanting to excel in the medical device industry. It is not a sit-back-and-relax course, the pace is fast and the course is demanding. Even so, 95% of participants report that it is the best course they have taken.
- Introduction to design control and key terms
- Project process
- The regulatory framework
- Classifcation and product approval
- Essential requirements, standards and guidelines
- Standards in medical device product development
- Introduction to project management
- What is enough?
- Medical device files
- The project process of the course
- Selecting tools and techniques
- Develop project charter
- Identify stakeholders
- General introduction
- Collect requirements
- Define design and development inputs
- How to manage requirements
- Define scope
- Risk management and usability engineering
- Plan verification and validation
- Create work breakdown structure
- Create schedule
- Develop human resource plan
- Project risk management
- Estimate cost and determine budget
- Develop project management plan
- Design review
- Direct and manage project execution
- Control schedule/control costs
- Control scope
- Manage communications
- Monitor and control risk
- Document pitfalls
- Design transfer
- Design verification and validation
- Design review
- Close project or phase
Are you interested in taking this Project Management classroom course?
Click on the button to request information for this course.
Frequently asked questions
Do I get a copy of the course presentation?
Yes, the course material includes a course binder with hand-out slides where a majority of the presented content is included.
Is the instructor accredited or certified to give this training?
The instructor maintains a PMP certification from the Project Management Institute. For the design control elements of the course, there is no certification or accreditation, however the instructor has conducted training in the field for many years and continuously participates in authoring standards such as the ISO 13485 and ISO 14971. Ensuring the instructor has the most up to date knowledge and information is the highest qualifications for teaching the course.
Can we have the course as an in-house course?
What are the pre-requisites for this course?
The sheer amount of dedication to the field shines through the enthusiastic and competent delivery that can be received by the inexperienced such as myself and seasoned veterans alike. Everyone I have talked to walks away with both new tools, techniques and approaches, but also an understanding of the essential forces that drive the development process. 5 out of 5 stars from me.