Project Management for Product Development of Medical Devices T: +46-708-186800
medicaldeviceHQ.com/contact
Project Management for Product Development of Medical Devices T: +46-708-186800
medicaldeviceHQ.com/contact
Project Management for Product Development of Medical
Devices
This project management course provides a high-level overview for developing a medical device, as well as providing the tools and techniques needed to get through a project. The course has an integrated approach to project management and design control requirements. Topics include: the level of documentation that is required, how to define requirements, the requirements that must be met to CE mark a product, how to budget and schedule to avoid cost and schedule overruns, risk management and usability engineering. The course covers both US and EU requirements and assumes you work with class II or higher class products.
All the subject matter of the Design Control course is also included within this course.
Date and locations
Course will be held at Radisson Blu Hotel, Östergatan 10, 211 25, Malmö, Sweden on 24-27 August 2020. Course will be held at Agern Alle 13, 2970 Hørsholm, Denmark on 2-5 November 2020.
Format
The course comprises lectures, interactive check-points and workshops. The instructor will follow up on learning objectives throughout the course, participants will have to answer questions on the topics covered to ensure that the objectives are met. Active participation and at least 75% attendance are required to be eligible for course certificates. The course is conducted in English.
Learning goals
The learning goals for this course are that you will: Advance your ability to successfully initiate, plan,
execute, control and close a medical device product development project
Increase your ability to finish projects on time and on
budget using the pragmatic methods, tools and techniques provided
Improve your understanding of why and how design
control requirements should be implemented within a project process
Increase your knowledge on the most common pitfalls
in medical device product development and how to avoid them
Project Management for Product Development of Medical Devices T: +46-708-186800
medicaldeviceHQ.com/contact
Thanks very much – this was one of the best courses I have been on in a long time. I enjoyed it a lot. The presenter was very knowledgeable and enthusiastic he had a good teaching style and answered questions well. The course gave me the perfect overview and was motivational and inspiring. It left me feeling much more confident and that I can do my job more effectively. I would definitely recommend this course to my colleagues.
- Shilpa Razdan, Regulatory Professional, GN Hearing A/S
Who should attend
R&D engineers wanting to become project managers consultants working with medical device projects project managers from other industries that have
moved to the medical device industry
medical device industry project managers
managers working directly or indirectly with projects
and product development
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.
Outline
Day 1 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
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
Fee
The course fee is 2,490 EUR including lunch and course materials (excl. VAT and living expenses). An early bird discount of 10% on the course fee (2,240 EUR) applies when you register 3 months or earlier before course start.
Video
Summary
Project Management for Product Development of Medical Devices
Hours 24
Days 4
Max number of participants 15 Start and finish 09:00-16:30
Risk management for medical devices and ISO 14971 T: +46-708-186800
medicaldeviceHQ.com/contact
Design Control for Medical Devices
The course is focused on how to develop new medical devices and maintain them in an organisation where design control requirements apply. The course addresses the level of documentation required and provides tools on how to work successfully and efficiently with design control. Since standards play a significant role in design control and development of medical devices, the course will reference the most commonly used standards that apply to medical devices. This includes ISO 14971 on risk management and IEC 62366 on usability engineering.
The participants will also learn about the most common pitfalls in medical device product development. The course covers both US and EU requirements and assumes you work with class II or higher class products. The course employs a lean and pragmatic approach to medical device design.
All the contents of this course are included in the Project Management for Product Development of Medical Devices course.
Date and locations
LIVE virtual course (3 non-consecutive workdays) on: 17, 22 & 24 June.
Courses will be held at Agern Alle 13, 2970 Hørsholm, Denmark on: 10-11 September 2020 & 7-8 October 2020
Format
The course comprises lectures, interactive checkpoints and workshops. The instructor will follow up on learning objectives throughout the course. This means that participants will have to answer questions on the topics
covered to ensure that the objectives are met. Active participation and at least 75% attendance are required to be eligible for course certificates. The course is conducted in English.
Learning goals
The learning goals for this course are that you will: Boost your efficiency in the development of medical
devices using the pragmatic methods, tools and techniques provided
Improve your understanding of how and why design
control requirements should be implemented
Increase your knowledge on the most common pitfalls
Design Control for Medical Devices T: +46-708-186800
medicaldeviceHQ.com/contact
Really informative and applicable, very well organised and implemented. A lot of lessons learned for me, that I will definitely share with colleagues in my next assignment. The practical exercises were useful and helped to enrich the discussions in a very positive way.
- Nadia Touma, Senior Consultant, Knightec AB Peter managed to keep the attention and interest of all the participants of the course for two full days. Even though the subject is quite complex and was new to most of the participants, they all seemed to be able to grasp the concept. Coming from pharma and now moving into Medical Device, this was quite an enlightening course. I give Peter my best recommendations.
- Kristine Lofthus, Head of QA, Oncoinvent AS
avoid them
Who should attend
Instruction is targeted towards professionals who are involved in the following areas:
the development of medical devices quality assurance
There are no pre-requisites, but it is helpful to have experience from product development in medical device industry or any other regulated industry or experience from the medical device industry in general.
Outline
Day 1 Introduction to Design control and key terms Project process
The medical device files The regulatory framework
Classification and product approval
Essential requirements, standards and guidelines Using standards in medical device product
development
Design and development inputs and traceability How to manage requirements
Day 2
Risk management and ISO 14971 Usability engineering
Design planning Design review
Design phase and design output Design transfer
Design verification and validation The product approval process What is enough?
Change control
Documentation pitfalls*
Fee
The course fee is 1,190 EUR including lunch and course materials (excl. VAT and living expenses). An early bird discount of 10% on the course fee (thus making your cost 1,071 EUR) applies when you register 3 months or earlier before course start.
Video
Summary
Design Control for Medical Devices
Hours 12
Days 2
Max number of
participants 20 Start and finish 09:00-16:30
Risk management for medical devices and ISO 14971 T: +46-708-186800
medicaldeviceHQ.com/contact
Risk Management for Medical Devices and ISO 14971:2019
This course will teach you how to work practically with risk management according to the requirements of the ISO 14971:2019 standard. The course covers all parts of the risk management process. This includes and orientation, an orientation on ISO 14971 risk management's relation to tools and techniques such as FMEA, P-FMEA and FTA. It is a practical course focusing on how to do things, rather than just requirements or principles from the standard. The course is packed with practical work that ensures you actually get to try your skills both in groups and individually. The number of participants is limited to 12.
Date and locations
Course will be held at Tivoli Hotel & Congress Centre, Arni Magnussons Gade 2-4, DK-1577, Copenhagen, Denmark on: 14-15 September, 2020.
Format
The course comprises lectures, interactive checkpoints and workshops. The instructor will follow up on learning objectives throughout the course. This means that participants will have to answer questions on the topics covered to ensure that the objectives are met. Active participation and at least 75% attendance are required to be eligible for course certificates. The course is conducted in English.
Learning goals
The learning goals for this course are that you will: Improve your understanding of the overall process of
risk management and how to create safe medical devices
Strengthen your ability to independently perform risk
analysis, risk evaluation and risk control
Build your capabilities in using risk management tools
such as FTA, FMEA and P-FMEA, and in understanding their differences
Who should attend
Instruction is targeted towards professionals who are involved in the following areas:
Risk Management for Medical Devices and ISO 14971 T: +46-708-186800
medicaldeviceHQ.com/contact
I was really happy with the course and am now much more confident on the subject. The presenter was very
knowledgeable and made the topic really interesting. I feel like I learnt a lot of things I can use in my everyday work. - Andres Olsen, Process Engineer, Contura International the development of medical devices
quality assurance
auditing of medical device companies There are no pre-requisites for this course.
Outline
Day 1
Introduction
What is risk management Why risk management
Standards relating to risk management The general requirements of risk management Risk analysis
Day 2
Risk evaluation Risk control
Risk management tools and techniques Overall residual risk acceptability Risk management review
Production and post-production activities
Fee
The course fee is 1,340 EUR including lunch and course material (excl. VAT and living expenses).
Video
Summary
Course Risk Management for Medical Devices and ISO 14971:2019
Hours 12
Days 2
Max number of
participants 12 Start and finish 09:00-16:30
Quality Management for Medical Devices and ISO 13485 T: +46-708-186800
medicaldeviceHQ.com/contact
Introduction to Risk Management for Medical Devices and ISO
14971:2019 (online)
This online course will introduce you to how to work practically with risk management according to the requirements of the new ISO 14971:2019 standard. The course covers all parts of the risk management process. This includes among other things, risk analysis, risk evaluation, risk control and an orientation on the standard's relation to tools and techniques such as FMEA and P-FMEA.
The course expires six months from the registration date. During this period, you can take the course as many times as you like. You can pause, and resume another day, and repeat lessons. The course even plays on mobile devices with internet connection.
The average time spent on the course is about 6-10 hours.
A course certificate with reference to the ISO 14971:2019 standard is awarded upon completion of a final exam at the end of the course.
The course is regularly taken by regulatory bodies from all over the world for training of auditors. The course costs 249 EUR per person. You can purchase this course on our website by clicking here.
To find out more information about this course and to watch our
FREE short course click
here
.
Quality Management for Medical Devices and ISO 13485 T: +46-708-186800
medicaldeviceHQ.com/contact
Introduction to Design Control for Medical Devices (online)
This online course will introduce you to the process of how to develop new medical devices and maintain them in organisations where design control requirements apply. The course mentions both European and US requirements and references the most commonly used standards that apply to medical devices. It also introduces tools on how to work successfully and efficiently with design control.
The course expires six months from the registration date. During this period, you can take the course as many times as you like. You can pause, and resume another day, and repeat lessons. The course even plays on mobile devices with internet connection.
The average time spent on the course is about 6-8 hours.
A course certificate is awarded upon completion of a final exam at the end of the course.
We recommend this course for people who are new in the field as well as professionals involved in the development of medical devices such as quality assurance, project management, design engineering or those involved in R&D and product development teams.
The course costs 249 EUR per person. You can purchase this course on our website by clicking here.
