Total Product Life Cycle : Clinical Phase

The term “clinical research” refers to studies, or trials, in which the device is tested in humans. Once a sponsor has sufficient pre-clinical data, the next step is to plan for clinical studies to establish the safety and effectiveness of the product. The Federal Food, Drug, and Cosmetic Act established a risk-based device classification system for medical devices. Each device is assigned to one of three regulatory classes Class I, Class II or Class III, based on the level of control necessary to provide reasonable assurance of its safety and effectiveness and the level of regulatory control. Read about the Total Product Life Cycle here »

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Clinical

Patient-Centered Identification of Meaningful Regulatory Endpoints for Medical Devices to Treat Parkinson’s Disease (PCOR Project Aim 1 Paper)

Patient-Centered Identification of Meaningful Regulatory Endpoints for Medical Devices to Treat Parkinson’s Disease (PCOR Project Aim 1 Paper)

A growing body of literature has developed identifying outcomes that matter to patients. The study that these published articles (Aims 1, 2 & 3 of MDIC’s PCOR project) are based on demonstrates an approach to identifying outcomes of medical devices for Parkinson’s...

MDIC Video Series: How to Maximize Patient Input in the Design and Development of Medical Device Clinical Trials

MDIC Video Series: How to Maximize Patient Input in the Design and Development of Medical Device Clinical Trials

MDIC created a “How-To” video series to accompany its report on Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials. The goal of this video series is to help medical device sponsors understand how to implement key recommendations...

Video Release of MDIC’s Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials

Video Release of MDIC’s Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials

In conjunction with its release of the Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials, MDIC issued a short video in which several experts involved in writing the report, including a patient who uses a medical device patient,...

MDIC’s Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials Report

MDIC’s Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials Report

This report provides a series of resources to help sponsors maximize patient input in their design and development of clinical trials. In particular, the report offers a series of best practices for device sponsors to identify and engage the “patient voice.”  By...

Parkinson’s Patients’ Tolerance for Risk and Willingness to Wait for Potential Benefits of Novel Neurostimulation Devices: A Patient-Centered Threshold Technique Study (PCOR Project Aim 2 paper)

Parkinson’s Patients’ Tolerance for Risk and Willingness to Wait for Potential Benefits of Novel Neurostimulation Devices: A Patient-Centered Threshold Technique Study (PCOR Project Aim 2 paper)

A growing literature has developed identifying outcomes that matter to patients. The study that these published articles (Aims 1, 2 & 3 of MDIC’s PCOR project) are based on demonstrates an approach to identifying outcomes of medical devices for Parkinson’s disease...

Best Practices for Communicating Benefit, Risk, and Uncertainty for Medical Devices Report

Best Practices for Communicating Benefit, Risk, and Uncertainty for Medical Devices Report

MDIC designed this report to be a practical resource to help professionals across the medical device community discuss medical device benefits, risks, and uncertainty in easy-to-understand language. While investigators, physicians, regulators, and others involved in...