TGFR Consulting LLC Concept Elaboration
Elaborating the concept integrates the results of the concept definition into a complete system definition, the design inputs.
Task and Preliminary Hazard Analysis
Task and preliminary hazard analysis identify the risk controls that a concept must implement to provide adequate product safety. Inputs Key Activities Outputs Clinical UseThe clinical use of the device Clinical Use Error DataData on the use errors and rates associated with the data. Clinical Hazards and HarmsThe clinical hazards and harms associated with the therapy. …
Early Concept Confirmation
Early concept confirmation allows the team to present the concept to customers for evaluation
Concept Development using Super Concepts
Evaluating specific concepts leverages the CTQs and VOB to determine the best overall concept. Evaluation uses an iterative approach, with several teams, and a scoring process using a Pugh Matrix. For each iteration, the Pugh Matrix scores the alternative concepts. Scoring against the weighted set of criteria (CTQs and the VOB) established during previous steps …
Identification of CTQs
User Needs can be transformed into Performance Parameters and through the QFD Process CTQs are identified. These CTQs will drive concept selection
Collecting VOC and VOB
Translating the Voice of the Customer (VOC) and Voice of the Business (VOB) into needs statements is critical to building the right product
Building the Right Product Introduction
Building the right product involves the translation of user and business needs into a product concept
Introduction to the 2nd Edition of the Cascade, Building a Medical Device
This is the intro to the 2nd Edition of the book “The Cascade, Building a Medical Device”
Basic Cybersecurity For Medical Devices
The FDA Guidance Content of Premarket Submissions for Management of Cybersecurity in Medical Devices has triggered an increased interest in cybersecurity for medical devices . This guidance from the FDA details the key elements for protecting the medical device. These elements form a hierarchy as Asset – anything that has value to an individual or …
Verification Test Planning
Test design needs to determine the right test level, minimize test overlap and ensure full coverage