Medical Device HQ
Course programme 2021
Why Medical Device HQ?
Medical Device HQ has been delivering world-class online training long before the word ‘virtual’ became fashionable.
From the moment you take your pre-course assessment, you will experience a different yet measurable way of learning, from our experienced and knowledgeable instructors.
In a day and age where all budgets need to be justified, Medical Device HQ provides you with more training for the same budget, while saving you time, travel expenses, and also doing your bit for the environment by reducing your carbon footprint.
If you are looking for an engaging medical device learning experience while having fun along the way, then you’ve come to the right place.
Blended courses
What kind of learner are you?
Are you all about requirements and processes, or do you prefer on the job training, where you actually use and implement as you go. The beauty of our blended courses is you get to do both.
Now the option is there for you to take the online course without the classroom sessions.
But the magic really happens when you combine or as we like to say, ‘blend ‘ the online training with our live, virtual classroom sessions.
Previous participants of our blended courses rate the experience with an average 4.8 out of 5 score.
Watch the video below to see why...
In-house courses
All our blended courses are also available as in-house courses. Request a proposal by emailing us on [email protected] and we’ll get back to you within 24 hours.
Risk Management for Medical Devices & 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 an orientation on ISO 14971 risk management's relation to tools and techniques such as FMEA and P-FMEA.
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.
Date of the next live virtual classroom session: 25th October 2021 @ 09:00-17:00 CET
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:
- the development of medical devices
- quality assurance
- auditing of medical device companies
There are no pre-requisites for this course.
Programme outline
Our blended courses are done in two parts: an online course (with a final exam) and a classroom session. You must achieve at least 85% in the final exam in order to participate in the classroom session. This is to ensure that everyone is at the same level in order to maximize learning.
Online course and course companion
The online course consists of a number of carefully scripted pre-recorded lessons with quiz questions throughout and a final exam at the end. You must have completed the online course and taken the final exam, achieving at least 85%, prior to the classroom session. You will receive a printed course companion in conjunction with the online course. The online course takes approximately 6-12 hours to complete.
Online course structure | |
Introduction (incl. pre-course assessment quiz) | Risk evaluation |
Introduction to risk management and tools and techniques | Risk control |
The regulatory background for risk management | Overall residual risk acceptability |
What is new in ISO 14971:2019 | Risk management review |
The general requirements of risk management | Production and post-production activities |
Risk Analysis - From hazard to harm | Usability engineering |
Risk analysis - Estimating risk | Final exam |
Classroom session and access to premium resources
The classroom session consists of a 1-day live virtual instructor-led classroom session where you will work on case studies and real-life scenarios.
This session also includes the following premium templates (regular price within brackets):
- Risk management SOP (€99)
- Risk management plan (€49)
- Hazard traceability matrix
- Risk management report (only available on live virtual class)
- Risk management file index (only available on live virtual class)
- Checklist ISO 14971:2007 to 14971:2019
All of the above templates are included for free.
Summary
Next classroom course session: 25th October 2021 @ 09:00-17:00 CET
Course fee: €899 including online course, printed course companion and premium templates.
Hours approx: 14-20 in total (6-12 hours online course + 8 hours classroom session)
Max number of participants: 8 per classroom session
Printed course companion: Yes
Templates: Yes
Course certificate: Yes
Taking the online course only?
You can take the online part of this course for €299 and opt in to take the classroom session after completing the online course. Register on this link for the online course.
Please note, the classroom session alone is priced €699, thus you will save €100 when registering for the blended course instead of purchasing them separately.
Anna Hedlund,
CareDx AB
This was my second course with Peter and I am happy to convey that this is still the best supplier of Medical Device courses that I have ever experienced. I highly recommend the online/blended course format, top quality all the way through!
Design Control for Medical Devices
This 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.
Date of the next live virtual classroom session: 20th & 21st October, 2021 @ 13:00-17:00 CET (you attend both)
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 in medical device product development and how to 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 the medical device industry or any other regulated industry or experience from the medical device industry in general.
Programme outline
Our blended courses are done in two parts: an online course (with a final exam) and a classroom session. You must achieve at least 85% in the final exam in order to participate in the classroom session. This is to ensure that everyone is at the same level in order to maximize learning.
Online course and course companion
The online course consists of number of carefully scripted pre-recorded lessons with quiz questions throughout and a final exam at the end. You must have completed the online course and taken the final exam, achieving at least 85%, prior to the classroom session. You will receive a printed course companion in conjunction with the online course. The online course takes approximately 6-12 hours to complete.
Online course structure | |
Introduction (incl. pre-course assessment quiz) | Design planning |
The project process | Design review |
Where do all requirements come from? | Design phase and design output |
Standards and guidance documents | Design transfer |
Product approval and classification | Design verification and validation |
Design and development inputs | Change control |
Risk Management | How it all fits together |
Usability engineering | Final exam |
Classroom session and access to premium resources
The classroom session consists of a 1-day live virtual instructor-led classroom session where you will work on case studies and real-life scenarios.
This session also includes the following premium templates (regular price within brackets):
- Design and development plan (€49)
- Design review
- Intended use and use specification (only available on live virtual class)
- Requirement traceability matrix (only available on live virtual class)
- Verification specification (only available on live virtual class)
- Standard search report (only available on live virtual class)
- Design and development SOP (only available on live virtual class)
All of the above templates are included for free.
Summary
Next classroom course session: 20th & 21st October, 2021 @ 13:00-17:00 CET (you attend both)
Course fee: €899 including online course, printed course companion and premium templates.
Hours approx: 14-20 in total (6-12 hours online course + 8 hours classroom session)
Max number of participants: 8 per classroom session
Printed course companion: Yes
Templates: Yes
Course certificate: Yes
Taking the online course only?
You can take the online part of this course for €299 and opt in to take the classroom session after completing the online course. Register on this link for the online course.
Please note, the classroom session alone is priced €699, thus you will save €100 when registering for the blended course instead of purchasing them separately.
Xabier Hernandez,
iLine Microsystems
I really enjoyed this Design Control online course, it was very well designed and structured, with good quality videos and charts throughout. The concepts were clearly presented and repeated to ensure understanding and the continuous evaluations worked brilliantly. I would definitely recommend this course!
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.
Date of the next live virtual classroom session: 21st & 22nd September 2021 @ 13:00-17:00 CET (you attend both)
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
Who should attend
Instruction is targeted towards professionals who are involved in the following areas:
- 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
The pre-requisite for this course is that you have successfully completed the Design Control for Medical Devices online course, preferably the full blended course.
Programme outline
Our blended courses are done in two parts: an online course (with a final exam) and a classroom session. You must achieve at least 85% in the final exam in order to participate in the classroom session. This is to ensure that everyone is at the same level in order to maximise learning.
Online course and course companion
The online course consists of number of carefully scripted pre-recorded lessons with quiz questions throughout and a final exam at the end. You must have completed the online course and taken the final exam, achieving at least 85%, prior to the classroom session. You will receive a printed course companion in conjunction with the online course. The online course takes approximately 10-16 hours to complete.
Online course structure | |
Introduction (incl. pre-course assessment quiz) | Estimating cost and determining budget |
Introduction to project management | Develop human resource plan |
Project charter development | Design review |
Identifying stakeholders | Direct and manage project execution |
Collecting requirements | Control schedule and costs |
Defining scope | Control scope |
Creating work breakdown structure | Managing communications |
Creating schedule | Monitor and control risk |
Developing a human resource plan | Close project or phase |
Project risk management | Final exam |
Classroom session and access to premium resources
The classroom session consists of a 1-day live virtual instructor-led classroom session where you will work on case studies and real-life scenarios.
This session also includes the following premium templates (regular price within brackets):
- Design and development plan (€49)
- Project charter (€29)
- Design review record
- Design transfer checklist
- Project close-out report
- Project deliverable list
- Project risk list
- Requirement traceability matrix
- Stakeholder register
- Status report
- Work breakdown structure
All of the above templates are included for free.
Summary
Next classroom course session: 21st & 22nd September 2021 @ 13:00-17:00 CET (you attend both).
Course fee: €1099 including online course, printed course companion and premium templates.
Hours approx: 18-24 in total (10-16 hours online course + 8 hours classroom session)
Max number of participants: 8 per classroom session
Printed course companion: Yes
Templates: Yes
Course certificate: Yes
Taking the online course only?
You can take the online part of this course for €449 and opt in to take the classroom session after completing the online course. Register on this link for the online course.
Please note, the classroom session alone is priced €799, thus you will save €150 when registering for the blended course instead of purchasing them separately.
Software for Medical Devices and IEC 62304
This is a software for medical devices course designed to teach you how to develop and maintain software for medical devices safely and according to the IEC 62304 standard.
Topics covered include: how to efficiently plan and document software development, getting requirements right, how to approach software architecture and software risk management, how to perform software safety classification correctly and working with SOUP/OTS software.
Date of the next live virtual classroom session: 26th & 27th October, 2021 @ 13:00-17:00 CET (you attend both)
Learning goals
The learning goals for this course are that you will:
- Understand the meaning of IEC 62304
- Develop software which is sustainable for the full life cycle
- Use risk management as a design tool
Who should attend
Instruction is targeted towards professionals who are involved in the following areas:
- R&D engineers involved in software development
- consultants working with software for medical devices
- the quality assurance department
- auditors of software development
Programme outline
Our blended courses are done in two parts: an online course (with a final exam) and a classroom session. You must achieve at least 85% in the final exam in order to participate in the classroom session. This is to ensure that everyone is at the same level in order to maximise learning.
Online course and course companion
The online course consists of number of carefully scripted pre-recorded lessons with quiz questions throughout and a final exam at the end. You must have completed the online course and taken the final exam, achieving at least 85%, prior to the classroom session. You will receive a printed course companion in conjunction with the online course. The online course takes approximately 10-16 hours to complete.
Online course structure | |
Introduction (incl. pre-course assessment quiz) | Software design |
Introduction to software and medical devices | Software testing |
Introduction to IEC 62304 | Software release and post release management |
Software risk management | Final exam |
Software planning |
Classroom session and access to premium resources
The classroom session consists of a 1-day live virtual instructor-led classroom session where you will work on case studies and real-life scenarios.
This session also includes the following premium templates:
- SOUP documentation (only available on the live virtual class)
- Software development plan (only available on the live virtual class)
- Software requirement verification (only available on the live virtual class)
- Hazard traceability matrix with software (only available on the live virtual class)
All of the above templates are included for free.
Summary
Next classroom course session: 26th & 27th October, 2021 @ 13:00-17:00 CET (you attend both)
Course fee: €1099 including online course, printed course companion and premium templates.
Hours approx: 18-24 in total (10-16 hours online course + 8 hours classroom session)
Max number of participants: 8 per classroom session
Printed course companion: Yes
Templates: Yes
Course certificate: Yes
Taking the online course only?
You can take the online part of this course for €449 and opt in to take the classroom session after completing the online course. Register on this link for the online course.
Please note, the classroom session alone is priced €799, thus you will save €150 when registering for the blended course instead of purchasing them separately.
Safety for Electrical Medical Devices and IEC 60601-1
This is a safety for electrical medical devices course designed to teach you how to identify and manage applicable safety related requirements throughout the design control process according to IEC 60601-1.
Topics covered include: proactive safety by design, identifying and managing requirements, internal verification, third party test and certification and product maintenance.
Date of the next live virtual classroom session: 12th & 13th October 2021 @ 13:00-17:00 CET (you attend both)
Learning goals
The learning goals for this course are that you will:
- Understand what basic safety for a medical device is
- Understand why and how basic safety is implemented and the most common pitfalls in medical device product development and how to avoid them
- Strengthen the participants' communication skills in the area of basic safety for medical devices
- Build an awareness of effective management of safety throughout the product lifecycle
Who should attend
Instruction is targeted towards professionals who are involved in the following areas:
- R&D engineers
- product specialists
- risk management specialists
- regulatory specialists
- the quality assurance department
Programme outline
Our blended courses are done in two parts: an online course (with a final exam) and a classroom session. You must achieve at least 85% in the final exam in order to participate in the classroom session. This is to ensure that everyone is at the same level in order to maximise learning.
Online course and course companion
The online course consists of number of carefully scripted pre-recorded lessons with quiz questions throughout and a final exam at the end. You must have completed the online course and taken the final exam, achieving at least 85%, prior to the classroom session. You will receive a printed course companion in conjunction with the online course. The online course takes approximately 10-16 hours to complete.
Online course structure | |
Introduction | General requirements |
Structure of the 60601 series of standards | Internal verification |
Key terminology | Third party test and certification |
Proactive safety by design | Product maintenance |
Identifying and managing requirements | Summary and conclusion |
Design and development | Final exam |
Classroom session and access to premium resources
The classroom session consists of a 1-day live virtual instructor-led classroom session where you will work on case studies and real-life scenarios.
This session also includes the following templates:
- IEC 60601-1 ed. checklist
- Insulation diagram
- Critical component checklist
- Insulation barrier table
- Test protocol
- Test plan
- Essential performance specification
All of the above templates are included for free.
Summary
Next classroom course session: 12th & 13th October 2021 @ 13:00-17:00 CET (you attend both)
Course fee: €1099 including online course, printed course companion and premium templates.
Hours approx: 18-24 in total (10-16 hours online course + 8 hours classroom session)
Max number of participants: 8 per classroom session
Printed course companion: Yes
Templates: Yes
Course certificate: Yes
Taking the online course only?
You can take the online part of this course for €449 and opt in to take the classroom session after completing the online course. Register on this link for the online course.
Please note, the classroom session alone is priced €799, thus you will save €150 when registering for the blended course instead of purchasing them separately.