Clinical Investigations and Evaluation for Medical Devices
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.

  • 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
  • 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

Clinical Investigations and Evaluation for Medical Devices

April 2 - 4, 2024, Live Online Training
Regular price $2,250
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

9:00 AM New York time

6:00 AM Los Angeles time

2:00 PM London time

Group discounts available upon request - contact us.

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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.

  • 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
  • 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

"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

Clinical Investigations and Evaluation for Medical Devices

Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.

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