Clinical Investigations and Evaluation for Medical Devices

Date to be announced

Price available after dates are announced

TRAINING TIMES

TBDVienna
TBDLondon
TBDNew York
TBDLos Angeles

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

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

TRAINER

James Pink

Health Sciences and Medical Devices Consultant

James Pink has over 25 years of experience in the medical devices industry including 10 years as a healthcare technology expert and lead auditor for a leading European notified body. He began his career as a product designer in the oil tools industry moving into medical physics and clinical engineering at the Royal Hallamshire Hospital in Sheffield, UK. His industry experience includes managing product development and quality assuranceprograms for active and non-active implantable and combination products. James is a contributor to several medical device standards committees including ISO13485, ISO 14971 and various product-related standards.

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