Project management for product development of medical devices

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.

Information on laws and regulations from CE Marking, risk management (ISO 14971), usability (EN 62366), software lifecycle processes (EN62304 and other standards are referenced within the course.

All the subject matter of the design control course is also included within this course

 

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 yourself


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.


Testimonials

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.

This was by far the most valuable course for my professional role that I have ever participated in. Super useful on several levels, highly recommendable!

Peter Sebelius is a very enthusiastic presenter with excellent style of delivery. He made an otherwise congested topic very interesting and kept participants motivated throughout the duration of the course. The course will help improve our professional performance as well as the quality of our work.


 

Course programme

Day 1

  • Introduction
  • Introduction to design acontrol and key terms
  • The regulatory framework
  • Classification and product approval
  • Essential requirements, standards and guidelines
  • Standards in medical device development
  • Introduction to project management
  • Project model
  • What is enough?
  • Medical device files

Day 2

  • 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

Day 3

  • Plan verification and validation
  • Create work breakdown structure
  • Create schedule
  • Develop human resource plan
  • Project risk management
  • Estimate cost and determine budget

Day 4

  • 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
  • Repetition

 

 

Would you prefer a course held on your premises?

We are naturally happy to hold courses on your premises. Simply contact us to discuss your requirements.

 

Frequently asked Questions


Yes, the course material includes a course binder with hand-out slides where a majority of the presented content is included.

For the course price, you will get the course, course material, templates , coffee and snacks throughout the day and snacks. For courses held in Hörsholm, also breakfast is included.

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 documented training in the field for many years and continuously participates in authoring standards such as the ISO 13485 and ISO 14971, making sure the instructor is up to date and has the highest qualifications for teaching the course.

The maximum number is 15. Any more than 15 people inhibits the interactive elements

Sure, I will be happy to send a proposal for a company internal version of this course to you. Use the contact form to request a proposal.

Recommended minimum pre-requisites for this course are any or all of the following: experience with product development in a regulated industry, experience from working in project organisation, or
with ISO 13485/21 CFR 820.

Yes, but only if you are present 75% or more of the course duration. You also have to be active on the course to be eligible for the certificate.

Please request the course programme by filling out the form below to get the programme including pricing and early bird discounts when applicable.

Please request the course programme by submitting the form below. Dates and venues are found for each course in the programme. The programme also contains more detailed information on the course than this page.

Register for a course

If you are already prepared to take a course, you can register for one of our upcoming courses using the registration form. You’ll have 24 hours to cancel your reservation in case you can’t come.

Get more info about the course

Enter your details below to request more information about our professional courses in medical device product development. Or simply call us on +46 708 186 800.