Clinical Investigations and Evaluation for Medical Devices

Course Description

This three-day course will give you a thorough overview of the clinical evaluation process for medical devices against the requirements of the Medical Device Regulation. You will leave with an understanding of the clinical evaluation process including details on the regulatory requirements, the principles of clinical evaluation, study design, and practical considerations for how they are performed and documented.

Key Topics

Regulatory requirements & pathways (EU, US and UK)
Study types & design
Clinical evidence – clinical development plan, clinical benefits
Clinical investigations – process, risk, parameters & design
Post-market surveillance
Medical device registries

Learning Objectives

Gain an update on the regulatory requirements
Understand different study types
Determine whether or not a clinical investigation is required
Understand sufficient quality & level of evidence requirements
Determine technical, biological, and clinical evidence for a development plan
Understand ‘state of the art’ in medicine
Assess the usability of medical devices registries

Who should attend?

Past participants

Our online training experience includes

FAQ

Clinical Investigations and Evaluation for Medical Devices

2 - 4 April 2024, Live Online Training

€1.850,00

Unit price: per

James Pink

James Pink has over 20 years of experience in medical devices including 10 years as a lead auditor for European Notified Body. James is a contributor to several medical device standards committees including ISO13485, ISO 14971 and various product-related standards.

START TIMES

3:00 PM Vienna time

2:00 PM London time

9:00 AM New York time

6:00 AM Los Angeles time

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Course Description

This three-day course will give you a thorough overview of the clinical evaluation process for medical devices against the requirements of the Medical Device Regulation. You will leave with an understanding of the clinical evaluation process including details on the regulatory requirements, the principles of clinical evaluation, study design, and practical considerations for how they are performed and documented.

Key Topics

Regulatory requirements & pathways (EU, US and UK)
Study types & design
Clinical evidence – clinical development plan, clinical benefits
Clinical investigations – process, risk, parameters & design
Post-market surveillance
Medical device registries

Learning Objectives

Gain an update on the regulatory requirements
Understand different study types
Determine whether or not a clinical investigation is required
Understand sufficient quality & level of evidence requirements
Determine technical, biological, and clinical evidence for a development plan
Understand ‘state of the art’ in medicine
Assess the usability of medical devices registries

Who should attend?

Past participants

Our online training experience includes

FAQ

"Trainer is very competent and has the complete knowledge of the matter."

– Senior Process Expert, B. Braun

"It is not at all frequent to find this grade of preparation and reaction to specific cases such as the ones presented. I'm enthusiastic! Thanks really."

– Tech Transfer Lead, Novartis

"Thank you for sharing all the links and informative material. Very professional organization and execution."

– Manufacturing Manager, Thermo Fisher Scientific

"The trainer was very knowledgeable about the topics and was able to answer all questions."

– Drug Product Subject Matter Expert, Pfizer

"Excellent work of the lecturer, good materials, clear explanations."

– Clinical Pharmacologist, Boehringer Ingelheim