HI-MT8 Clinical Evaluation and Data analysis – for Medical Devices

Learn how to integrate clinical evaluation into your product development processes

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Course Information

1 day
10 December 2024

Investment

The investment is €795,- per participant (ex. VAT).

Included are a digital learning
environment with the course
material, hands-on tools,
beverages and lunch

Clinical Evaluation and Data analysis – for Medical Devices

The objective of this course is to provide participants with knowledge of the requirements for Clinical Evaluation and Post-Market Surveillance (PMS) (ISO/TR 20416:2020) as set out in the Medical Device Regulation (MDR 2017/745), including Clinical Investigation (ISO 14155). This training is designed for medical device professionals who wish to increase their knowledge and understanding of clinical evaluation and post-market surveillance (PMS). It is highly recommended for individuals who are responsible for conducting clinical evaluation and/or post-market surveillance within their organization.

Additionally, this training is well-suited for companies who want to improve their PMS and are looking for guidance on how to effectively manage the data collected post market. While prior experience with the Medical Device Regulation (MDR) is beneficial, it is not essential for attending this training program.

What will you learn

Our training offers a comprehensive understanding of the impact of the intended purpose of a medical device (device claims) on Clinical Evaluation.
Participants will learn practical and ‘hands-on’ compliance with MDR and ISO14155 for medical device development and how to integrate clinical studies into your product
development process.

In addition, the course will cover the effective use of data analysis in clinical trials, clinical
performance evaluation, and PMS.

Program:

The impact of medical device claims on the clinical evaluation process
What clinical data is required throughout the lifecycle of your medical device according to the EU MDR
How to conduct literature searches and reviews to identify available data
The clinical investigation requirements and when this clinical investigation is
required
The key differences between the following types of clinical investigations and the regulatory requirements that apply to each:
- Clinical investigations conducted for research purposes to further design and development
- Clinical investigations conducted for conformity assessment of your medical device
- Clinical investigations conducted after market approval (Post Market Clinical follow up)
Basic statistical concepts for the design, analysis and reporting of clinical investigations
The key elements of the Clinical
Evaluation Report

Learnings:

How to prepare and conduct clinical
evaluation and PMS using a risk-based
approach
The importance and requirements for post market clinical follow-up (studies)

How PMS data can be used to
perform reliability trend analysis,
performance evaluation, and
complaint trend analysis
How to provide effective feedback
towards the design and development
process based on PMS data.

Instructors

Monique van Lier

Medical Device Development Expert

Monique is a Medical Device Development Expert, with a special focus on clinical evaluation, clinical application training, and post market surveillance. As a pragmatic team player with a result-oriented mindset, Monique is committed to involve users in the product development process.

Register now by filling in the following form.

After your registration, we will schedule an intake by telephone with you . During this conversation we will discuss the training content, how this training will help you with your challenges and any further questions.

Clinical Evaluation and Data analysis – for Medical Devices

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Practical information.

For whom

This training is designed for medical device professionals who wish to increase their knowledge and understanding of clinical evaluation and post-market surveillance (PMS). It is highly recommended for individuals who are responsible for conducting clinical evaluation and/or post-market surveillance within their organization.