Phantoms for performance verification and quality control in developing a photonics-based medical device (VASCOVID): a regulatory driven approach

2021 ◽  
Author(s):  
Sanathana Konugolu Venkata Sekar ◽  
Claudia Nunzia Guadagno ◽  
Marta Zanoletti ◽  
Lorenzo Cortese ◽  
Marco Pagliazzi ◽  
...  
Keyword(s):  
Quality Control ◽  
Medical Device ◽  
Performance Verification

scholarly journals 27A medical device grade T2 phantom to quality control inflammation imaging by CMR

2019 ◽  
Vol 20 (Supplement_2) ◽  
Author(s):  
H S Seo ◽  
G Captur ◽  
B Ittermann ◽  
W Pang ◽  
K Keenan ◽  
...  
Keyword(s):  
Quality Control ◽  
Medical Device ◽  
Inflammation Imaging

scholarly journals Recommendation for performance verification of patient-based real-time quality control

2020 ◽  
Vol 58 (8) ◽  
pp. 1205-1213 ◽  
Author(s):  
Tze Ping Loh ◽  
Andreas Bietenbeck ◽  
Mark A. Cervinski ◽  
Huub H. van Rossum ◽  
Alex Katayev ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Quality Control ◽  
Real Time ◽  
Moving Average ◽  
Quality System ◽  
Performance Verification ◽  
Realistic Representation ◽  
Verification Process ◽  
Laboratory Tool ◽  
Exponentially Weighted

AbstractPatient-based real-time quality control (PBRTQC) is a laboratory tool for monitoring the performance of the testing process. It includes well-established procedures like Bull’s algorithm, average of nomals, moving median, moving average (MA) and exponentially (weighted) MAs. Following the setup and optimization processes, a key step prior to the routine implementation of PBRTQC is the verification and documentation of the performance of the PBRTQC as part of the laboratory quality system. This verification process should provide a realistic representation of the performance of the PBRTQC in the environment it is being implemented in, to allow proper risk assessment by laboratory practitioners. This document focuses on the recommendation on performance verification of PBRTQC prior to implementation.

RISK-BASED TESTING APPROACH FOR MEDICAL DEVICES SOFTWARE

2020 ◽  
Vol 70 (4) ◽  
Author(s):  
Ivan Ivanov ◽  
V. Gueorguiev ◽  
D. Georgieva ◽  
M. Nenova ◽  
B. Ivanov
Keyword(s):  
Quality Control ◽  
Quality Assessment ◽  
Medical Device ◽  
Medical Devices ◽  
Development Process ◽  
Functional Requirements ◽  
Device Development ◽  
Stage Of Development ◽  
Requirements Specifications ◽  
Testing Approach

A successful "medical device" development requires the collaboration be-tween designers, developers, and quality engineers to be able to assess needs, functional requirements, specifications, and problems at every stage of development. The quality control of the developing process is achieved through a predefined set of policies, quality assessment, and the management of activities to eliminate defects and weaknesses wherever the development process.

Hemoglobin assay for validation and quality control of medical device reprocessing

2015 ◽  
Vol 407 (22) ◽  
pp. 6885-6889 ◽  
Author(s):  
Justin Frey ◽  
Allan Guan ◽  
Zhenyu Li ◽  
Steven Turtil ◽  
K. Scott Phillips
Keyword(s):  
Quality Control ◽  
Medical Device ◽  
Medical Device Reprocessing
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