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.

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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) 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.

Mark Lindhardt

Junior Engineer, Andreasen & Elmgaard A/S

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! Anna Hedlund

Head R&D , Olerup SSP AB

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. Pim Poldervaart

Development Engineer, Vertex-Dental, Netherlands

Course Program

Introduction to design control and key terms
Project process
The regulatory framework
Classification 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
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.

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

Course Category

PUBLIC COURSE / IN-HOUSE COURSE

Course Length

4 days

Upcoming Courses

25 March, 2019

Course Fee (per person)

€ 2490

90-day Early Bird Special

€ 2240

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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.

Are you 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 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.

What is the maximum number of participants?

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

Can we have the course as a company internal course?

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.

What are the pre-requisites for this course?

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.

If I can’t attend the course 100% of the time, will I still get a certificate?

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.

How much is the course?

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

When and where is the course held?

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.