Make sure you are ISO14155 certified if you would like to be MDR compliant!

How to Implement

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

good clinical practice for

clinical investigations with medical devices

In a practical and easy waY

Make sure you are ISO14155 certified if you would like to be MDR compliant!

How to Implement

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!

450

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:

Wasted Time...
Wasted Money...
Frustration Etc...

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

Make sure you are compliant with this new version of the ISO14155 before the MDR application date (26th of May 2021!), as by then 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 new version of the ISO14155 before the MDR application date (26th of May 2021!), as by then 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

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

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

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

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

”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

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

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

450

Total value €995