GET CERTIFIED NOW: ISO14155 E-LEARNING TRAINING
if you would like to be MDR compliant!
How to Implement
ISO14155 - good clinical practice for
clinical investigations with medical devices
In a practical and easy waY
Make sure to book your training on Black Friday to get 50% discount on all trainings. The offer expires soon!
How to Implement
good clinical practice for
clinical investigations with medical devices
In a practical and easy waY
Make sure to book your training soon to get 50% discount on all trainings. The offer expires soon!
How to Implement
ISO14155 - good clinical practice for
clinical investigations with medical devices
In a practical and easy waY
GET CERTIFIED NOW:
ISO14155 E-LEARNING TRAINING
if you would like to be MDR compliant!
How to Implement
ISO14155 - good clinical practice for
clinical investigations with medical devices
In a practical and easy waY
This training is especially important for any party involved in clinical investigations with medical devices, who are looking for answers on how to practically implement the Good Clinical Practice into their daily practice.
Get yourself certified on The ISO14155:2020, the Good Clinical Practice for Medical Device Clinical Investigations, including a lot of bonuses for a limited time!
495
This training is especially important for any party involved in clinical investigations with medical devices, who are looking for answers on how to practically implement the Good Clinical Practice into their daily practice.
Get yourself certified on The ISO14155:2020, the Good Clinical Practice for Medical Device Clinical Investigations, including a lot of bonuses for a limited time!
225
Limited offer 50% discount
More and more emphasis is being put on sufficient clinical evidence by the Notified Bodies.
You maybe thought by reading the ISO14155:2020 standard:
You would learn the practical tools of implementing it into your daily practice. However, you had to first pay approximately €200 to get your license and access to it, then spend your valuable time in reading the 90 pages, in order for you to conclude:
You can read it 20 times and still struggle with the so-called “grey areas”, where the standard doesn’t give you the answers to your questions.
This is exactly what I experienced a year ago.
No matter the number of times I went through the document, still situations occurred where I could not find the answers that I was looking for.
I had to invest a lot of time
in additional trainings, congresses, discussions with other experts, in order to understand what the “Good Clinical Practice” actually meant in those situations.
I’ve shared my knowledge
through a 1-day face-to-face ISO14155:2020 training, because I like getting to know the group and jump into the burning questions as they come along and from my experience a lot of trainees like having direct contact with their trainer this way.
Until the Corona virus pandemic came along, which forced me to switch to online face-2-face trainings, in order for me to find out:
For a lot of interested parties it just wasn’t matching with their daily agenda or they felt uncomfortable in sharing their daily problems in an online environment where they did not know the other parties also attending!
One thing the pandemic has taught us, is how we can embrace the online options...
...the world is ready for e-learning...
I'm on a mission to help others just like you, by sharing all my knowledge I've gained over the years in a flexible way!
Unlike other trainings,
this e-learning training actually teaches you how to translate the standard into your daily practice in your own free time.
Because let’s face it:
In reality, not everything is black & white!
imagine a way of learning that is:
Practical...
An interpretation of the regulation is given by practical examples, that is fast and easy to implement in your daily practice
Easy to remember...
Scientifically proven methods are used, to better remember and understand the content
Flexible...
You have control over your time, by scheduling this training whenever you can make yourself available
So you can actually focus on
saving patients’ lives & giving
better treatment options
by bringing them fast innovation...
Without:
A selection of organizations that preceded you:
The ISO14155:2020, the Good Clinical Practice for
Medical Device Clinical Investigations
In this e-learning you will get valuable, state-of-the-art information on the interpretation and implementation of the Good Clinical Practice in your clinical investigations with medical devices.
You learn how to:
• add credibility to your clinical data
• protect your subject’s rights & safety
• worldwide acceptance of your data
• no more findings during inspections
• avoid unnecessary risk for patients
• avoid unnecessary regulatory delay
• implement the regulation
• including practical solutions
Choose the In-Depth Training:
included in the In-Depth training:
Module 1:
Scope
• ISO14155 versus other GCP documents
• Scope of ISO14155
• Applicability of ISO14155
• Summary of the GCP principles
• References
Module 2:
Ethical Considerations
• Ethical considerations
• Informed consent process
Module 3:
Clinical Investigation Planning
All activities regarding the investigation planning phase, including:
• Risk assessment
• Justification of the investigational design
• CIP, IB and CRF requirements
• Monitoring plan
• Site selection
• Investigation agreements
• Labelling requirements
• Setup of a data monitoring committee
Module 4:
Clinical Investigation Conduct
All activities to be performed from the start and throughout the duration of the clinical investigation, including:
• Site initiation and monitoring
• Adverse event and device deficiency reporting
• Documents and documentation
• How to manage new site personnel
• How to guarantee subject's privacy
• How to perform document and data control
• How to account for all subjects
• Any relevant auditing requirements
Module 5:
Clinical Investigation Close Out
All requirements for:
• Premature terminations or suspensions
• The decision to restart the investigation
• Routine close out
Module 6:
Sponsor Responsibilities
• Quality Assurance
• Selection of Clinical Personnel
• Documents and Materials Preparation
• Clinical Investigation Conduct
• Monitoring
• Safety Evaluation and Reporting
• Outsourcing of Duties and Functions
• Communication with Regulatory Authorities
Module 7:
Principal Investigator Responsibilities
• Qualifications of the Principal Investigator
• Qualification of the Investigation Site
• Communication with the EC
• Informed Consent Process
• Compliance with the CIP
• Medical Care of Subjects
• Safety Reporting
Or go for the VIP Training:
included in the VIP training:
Full In-Depth Training:
See description above what is included in the In-Depth Training
• Module 1: Scope
• Module 2: Ethical Considerations
• Module 3: Clinical Investigation Planning
• Module 4: Clinical Investigation Conduct
• Module 5: Clinical Investigation Close Out
• Module 6: Sponsor Responsibilities
• Module 7: Principal Investigator Responsibilities
Exclusive 1 hour 1:1 Q&A
• Ask me all your questions that you have
• Get practical solutions to your problems
Or choose the Basic Training:
included in the basic training:
Module 3:
Clinical Investigation Planning
All activities regarding the investigation planning phase, including:
• Risk assessment
• Justification of the investigational design
• CIP, IB and CRF requirements
• Monitoring plan
• Site selection
• Investigation agreements
• Labelling requirements
• Setup of a data monitoring committee
Module 4:
Clinical Investigation Conduct
All activities to be performed from the start and throughout the duration of the clinical investigation, including:
• Site initiation and monitoring
• Adverse event and device deficiency reporting
• Documents and documentation
• How to manage new site personnel
• How to guarantee subject's privacy
• How to perform document and data control
• How to account for all subjects
• Any relevant auditing requirements
Module 5:
Clinical Investigation Close Out
All requirements for:
• Premature terminations or suspensions
• The decision to restart the investigation
• Routine close out
what people are saying about THIS TRAINING
"Rianne Tooten knows what she is talking about and can convey the material well and clearly. Her enthusiasm and practical examples in particular help enormously to make the theory practical and understandable. I can recommend everyone to follow this course"
Maarten Hieltjes,
Scientist at Philips Research
”The training was extremely valuable for me, since I'm applying for investigation approval as a PI.
The training helped me a very great deal in preparing the application material, planning the investigation and organizing all processes involved. I was afraid that the material would be very confusing and rather boring, but Rianne made the information digestible and even interesting.
Even after I passed the test, I have watched all the videos at least 2 times, and it has been a great help during investigation planning. I absolutely recommend this training!"
Prof. dr. Gutierrez-Farewik
Professor of Biomechanics at KTH Royal Institute of Technology
"Rianne Tooten's course was tremendously helpful when many regulations and standards continuously changed.
The ISO14155:2020 training course was laid out in plain English and easily understood. I recommend this class to anyone interested in ethical considerations, clinical investigation planning, conduct and closeout, Sponsor, and PI responsibilities described in ISO 14155:2020"
Loletia Carter
Lead auditor at Cannon Quality Group
Make sure you are compliant with this ISO14155:2020 version when applying for a MDR CE certificate, as the MDR makes it critical for all clinical investigations to apply this international standard.
Valid only on Black Friday: November 26th 2021 50% discount on all packages!
Discount code: BLACKFRIDAYDEALS
Make sure you are
compliant with this ISO14155:2020 version when applying for a MDR CE certificate, as the MDR makes it
critical for all clinical investigations to apply this international standard.
Upon completion of this training, you will be able to correctly and successfully:
• Comprehend and apply the requirements of the ISO 14155 as a GCP guidance specifically for medical device clinical investigations from start to finish
• Understand how risk management is applied to all aspects of medical device clinical investigations
• Comprehend the different types of clinical investigation study designs and how ISO 14155’s requirements apply
• Adapt your procedures to the new requirements compared to the ISO14155:2011 version
Extra bonuses:
Bonus Visual Summary (value €50)
Compact visual summary of each module with clear take away messages, reminding you on the essentials of each phase of the clinical investigation
Bonus 2020 vs 2011 version (value €250)
Differences between the 2020 version compared to the old 2011 version
Bonus Practical Examples (value priceless)
Comprehensive and practical guidance on how to implement the requirements - including many examples
100% GUARANTEE!
If you’re not 100% satisfied with the training within 14 days, I will offer you a full refund.
Make your payment today, and you don’t even have to decide if you’re in for good!
Take the full 14 days to explore the materials and experience the vibe of the Training on the ISO14155:2020 and THEN... make a decision using the information YOU HAVE, rather than the information you don’t.
choose the package, that suits you best:
Basic
147,50
Limited offer 50% off
295
Total value €595
2 hours of valuable, state-of-the-art training
on Module 3, 4, 5
(value €295)
BONUS: Visual summaries
(value €50)
BONUS: Differences between the
2020 version and 2011 version
(value €250)
BONUS: Practical guidance and examples
(value priceless)
Introduction in clinical research, ideal for starters
VIP
297,50
Limited offer 50% off
595
Total value €1145
1 hour 1:1 Q&A
(value €150)
Full In-Depth Training, including all bonuses
(value €995)
Deep-dive in clinical research, ideal for researchers who want answers to their specific questions
In-Depth
225
Limited offer 50% off
450
Total value €995
5 hours of valuable, state-of-the-art training
on Module 1 till 7
(value €695)
BONUS: Visual summaries
(value €50)
BONUS: Differences between the
2020 version and 2011 version
(value €250)
BONUS: Practical guidance and examples
(value priceless)
Deep-dive in clinical research, ideal for researchers who want to know all the details
choose the package, that suits you best:
Basic
350
Total value €595
2 hours of valuable, state-of-the-art training
on Module 3, 4, 5
(value €295)
BONUS: Visual summaries
(value €50)
BONUS: Differences between the
2020 version and 2011 version
(value €250)
BONUS: Practical guidance and examples
(value priceless)
Introduction in clinical research, ideal for starters
VIP
695
Total value €1145
1 hour 1:1 Q&A
(value €150)
Full In-Depth Training, including all bonuses
(value €995)
Deep-dive in clinical research, ideal for researchers who want answers to their specific questions
In-Depth
495
Total value €995
5 hours of valuable, state-of-the-art training
on Module 1 till 7
(value €695)
BONUS: Visual summaries
(value €50)
BONUS: Differences between the
2020 version and 2011 version
(value €250)
BONUS: Practical guidance and examples
(value priceless)
Deep-dive in clinical research, ideal for researchers who want to know all the details
what people are saying about THIS TRAINING
”What a great training! It was set up that all could be followed with even limited or no medical device experience. A nice extention and refresher on my broad clinical knowledge"
Femke Overmars
Freelance CTM, srCRA
"The training is very informative and easy to follow for clinical research professionals with or without Medical Device Trial experience"
Alberta Huisman,
Freelance CRA
Regulatory Authorities, in many countries,
have reported multiple disturbing cases
of non-compliance over the last decades.
We all have heard about the leaking breast
implants, surgical meshes,
metal-on-metal hip implants,
that have caused many patients
to suffer from traumatic complications.
Which have led to the upcoming
changes in the regulation and
sharpened scrutiny systems.
Not only the manufacturers need to adhere to the MDR, also investigators, regulatory authorities and Notified Bodies.
So, let’s stop talking about the “why?” and get yourself ready!
choose the package, that suits you best:
Basic
147,50
Limited offer 10% off
295
Total value €595
2 hours of valuable, state-of-the-art training
on Module 3, 4, 5
(value €295)
BONUS: Visual summaries
(value €50)
BONUS: Differences between the
2020 version and 2011 version
(value €250)
BONUS: Practical guidance and examples
(value priceless)
Introduction in clinical research, ideal for starters
VIP
297,50
Limited offer 50% off
595
Total value €1145
1 hour 1:1 Q&A
(value €150)
Full In-Depth Training, including all bonuses
(value €995)
Deep-dive in clinical research, ideal for researchers who want answers to their specific questions
In-Depth
225
Limited offer 50% off
450
Total value €995
5 hours of valuable, state-of-the-art training
on Module 1 till 7
(value €695)
BONUS: Visual summaries
(value €50)
BONUS: Differences between the
2020 version and 2011 version
(value €250)
BONUS: Practical guidance and examples
(value priceless)
Deep-dive in clinical research, ideal for researchers who want to know all the details
choose the package, that suits you best:
Basic
350
Total value €595
2 hours of valuable, state-of-the-art training
on Module 3, 4, 5
(value €295)
BONUS: Visual summaries
(value €50)
BONUS: Differences between the
2020 version and 2011 version
(value €250)
BONUS: Practical guidance and examples
(value priceless)
Introduction in clinical research, ideal for starters
VIP
695
Total value €1145
1 hour 1:1 Q&A
(value €150)
Full In-Depth Training, including all bonuses
(value €995)
Deep-dive in clinical research, ideal for researchers who want answers to their specific questions
In-Depth
495
Total value €995
5 hours of valuable, state-of-the-art training
on Module 1 till 7
(value €695)
BONUS: Visual summaries
(value €50)
BONUS: Differences between the
2020 version and 2011 version
(value €250)
BONUS: Practical guidance and examples
(value priceless)
Deep-dive in clinical research, ideal for researchers who want to know all the details
FREQUENTLY ASKED QUESTIONS
How much time is required?
This is depending on the package:
• The Basic training takes you approximately 2 hours to complete.
• The In-Depth and VIP training approximately 5 hours.
• The VIP package adds a 1 hour Q&A to the In-Depth training.
How much can I save?
This training asks for a little time and money investment; however, I can guarantee that in the end this training is worth the investment and will save you a lot of money and time! It will teach you which steps to follow in planning, conducting and closing your clinical investigation, which ultimately pays off in time and money. So why invent the wheel if you can learn it by following this training? Which will save you from possible delays and costs in obtaining regulatory approvals or countries not accepting your clinical data or possible major findings by regulatory inspections.
I don’t have a job yet in the field of clinical research with medical devices. Do I need this training?
If you are looking for a job in the field of clinical research with medical devices, I can recommend following this training, as this will add value to your application. This training provides you with a good introduction on what to expect when working in this field and sets the basis when you start. You will understand the terminology that is being used, which you can use when applying for a job.
How long do I have to complete the training?
You have 60 days full access to the full content of this training and to complete the test and earn your certificate. After the 60 days, your login will expire. Of course, you will be reminded per email about this, so no need to worry about this. You can have the option to prolong your access for another 30 days, 6 months or 1 year, as will be explained in the reminder email with links to the different prolongation options.
I already have a lot of experience in ICH-GCP. Will this training still work for me?
Yes, ICH-GCP generally does not apply to medical device clinical investigations. In this training you will learn why and the major differences.
What if I have already completed a training on the ISO14155:2011 version? Is this training still needed?
The MDR requires all clinical investigations to be conducted according to the latest version of the ISO14155. This training focusses on the new 2020 version in which the differences compared to the old 2011 version are highlighted.
Will I get accreditation points when following this training?
The In-Depth ISO14155 training is acknowledged by the Royal Dutch Medical Association (RDMA). RDMA (KNMG in Dutch) is the professional organization for Dutch doctors.
The KNMG is an active member of the Comité Permanent des Médecins Européens (CPME), the European association of doctors. The CPME is committed to the quality of medical practice and physician training across Europe in order to achieve the highest level of healthcare for all patients in Europe.
ABAN and V&VN have granted the In-Depth ISO14155 training with 4 accreditation points.
Dutch healthcare professionals with a BIG registration number can apply for the accreditation, by leaving their BIG registration number on the checkout form when buying either the “In-Depth ISO14155 training” or the “VIP ISO14155 training”.
What kind of support can I get if I get stuck?
If you encounter any technical problems, feel free to send an email to info@riannetooten.nl. I will typically respond within 48 hours!
Do I need to use a special program to access the materials?
This training can be followed in every internet browser that is currently available. In addition, you can download the visual summaries and reference documents by using adobe. If you do not have adobe on your computer yet, you can download it for free here.
Are You Ready For The Upcoming MDR and
Transforming Your Current Daily Practice
to a Good Clinical Practice?
Here’s the truth:
Trainings on regulations aren’t always the fun thing to do. You would like to spend your valuable time on bringing fast innovations to your patients and not on another training, that might feel as boring or a waste of your time.
However, it can be frustrating if your hard work on your clinical investigation or product and the time and money you have already invested in it, is not rewarded by a fast approval of your clinical investigation by the Ethics Committee or your Notified Body has not granted your product with fast market access.
• With this e-learning training, I’m giving you the flexibility to train yourself in your own time.
• With a bit of a personal touch (you can actually meet me online), fun and color, I’ll share with you my long-term experience and valuable practical examples in a fun and colorful way. So you will remember how to interpretate and implement the ISO14155 standard.
• It are those GREY areas that keep us sharp and where we can actually use our creative minds in translating the standard into your daily practice.
Because let’s face it:
In reality not everything is BLACK & WHITE!
Basic
147,50
Limited offer 150% off
295
Total value €595
2 hours of valuable, state-of-the-art training
on Module 3, 4, 5
(value €295)
BONUS: Visual summaries
(value €50)
BONUS: Differences between the
2020 version and 2011 version
(value €250)
BONUS: Practical guidance and examples
(value priceless)
Introduction in clinical research, ideal for starters
VIP
297,50
Limited offer 10% off
595
Total value €1145
1 hour 1:1 Q&A
(value €150)
Full In-Depth Training, including all bonuses
(value €995)
Deep-dive in clinical research, ideal for researchers who want answers to their specific questions
In-Depth
225
Limited offer 50% off
450
Total value €995
5 hours of valuable, state-of-the-art training
on Module 1 till 7
(value €695)
BONUS: Visual summaries
(value €50)
BONUS: Differences between the
2020 version and 2011 version
(value €250)
BONUS: Practical guidance and examples
(value priceless)
Deep-dive in clinical research, ideal for researchers who want to know all the details
choose the package, that suits you best:
Basic
350
Total value €595
2 hours of valuable, state-of-the-art training
on Module 3, 4, 5
(value €295)
BONUS: Visual summaries
(value €50)
BONUS: Differences between the
2020 version and 2011 version
(value €250)
BONUS: Practical guidance and examples
(value priceless)
Introduction in clinical research, ideal for starters
VIP
695
Total value €1145
1 hour 1:1 Q&A
(value €150)
Full In-Depth Training, including all bonuses
(value €995)
Deep-dive in clinical research, ideal for researchers who want answers to their specific questions
In-Depth
495
Total value €995
5 hours of valuable, state-of-the-art training
on Module 1 till 7
(value €695)
BONUS: Visual summaries
(value €50)
BONUS: Differences between the
2020 version and 2011 version
(value €250)
BONUS: Practical guidance and examples
(value priceless)
Deep-dive in clinical research, ideal for researchers who want to know all the details
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