HI-MT3 Clinical Evaluation and Data Analysis

Learn how to integrate 
clinical evaluation into your product development processes

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Course Information

  • 1 day
  • 20 November 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

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

Lisanne Nannings

Lisanne Nannings

Medical Device Development Specialist
With a background in technical medicine, Lisanne specializes in clinical evaluation and focuses on ensuring that medical devices meet safety and efficacy standards. She is passionate about contributing to the development of new medical technologies that can improve healthcare and the quality of life for patients.
Monique van Lier

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.
Dr. Ir. Coen Smits

Dr. Ir. Coen Smits

Scientific Director Reliability
He has been with Holland Innovative for over 10 years as a reliability specialist with assignments in many high tech and automotive organizations. He holds a Ph.D. in Applied Physics from the Eindhoven University of Technology.

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.

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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. 


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.

 

Certificate

Participants receive a certificate of participation.

Location & dates

Locations

The Gallery, Hengelosestraat 500, Enschede 
High Tech Campus 9, Eindhoven

Dates 2024

Session I: November 20

Groepsgrootte 

Een minimum van 8 participanten, met een maximum van 12 participanten. 


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