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Overview of Exempt Medical Device Clinical Studies

May 15, 2016 - Lael Pickett; and Liz Scheurer, Principal Clinical Research Scientist, Neurocritical Care

The white paper “Overview of U.S. Medical Device Clinical Trials” provided a brief overview of US clinical studies regulations, the types of clinical studies and how to determine if an Investigational Device Exemptions (IDE) is required. This paper will focus on studies that are “Exempt” or rather, do not require an IDE application be filed with FDA for pre-study approval.



Overview of U.S. Medical Device Clinical Trials

March 8, 2016 - Liz Scheurer, Principal Clinical Research Scientist, Neurocritical Care; and Lael Pickett

Clinical study conduct and design is always a challenge, with patient safety being at the forefront of that challenge. From an initial study concept, a company (“Sponsor”) must assess and implement decisions that will guide the project to the desired end. Is the study focusing on an iteration or small design change to an existing device or software? Is the device, therapy or expected action something novel, and is the study a “first-in-human” with the end result being a determination of “Is it safe and does it work?” This paper will provide a brief overview of US clinical studies regulations, the types of clinical studies and how to determine if an Investigational Device Exemptions (IDE) is required.



Formal Testing of Requirements

February 8, 2016 - Rebecca Haag, Systems Engineer II; and Gary Seim, Principal Systems Engineer, Retired

After requirements have been elicited, captured, agreed to and managed, a detailed design has been developed and implemented and integration testing is complete, the last phase of the development effort is reached: Formal Testing.



Requirements Elicitation

January 8, 2016 - Rebecca Haag, Systems Engineer II; and Gary Seim, Principal Systems Engineer, Retired

Requirements represent a translation of customer needs into a contract that designers can utilize to drive the development of the product and that can impact a project’s schedule, budget, and quality output. This paper will explore the process of eliciting requirements, including: determining who should participate, creating opportunities to extract/obtain requirements, and generating meaningful user discussions.



Requirements Management

December 4, 2015 - Rebecca Haag, Systems Engineer II; and Gary Seim, Principal Systems Engineer, Retired

The impact of requirements extends beyond the initial agreement and continues throughout the project to ensure that requirements are appropriately documented and traced and that changes are controlled.