Imaging/Image Quality Standards

#1
For a Class IIb SaMD for advance visualization, image reading and reporting, what are the applicable Imaging standards. I have a short list - DICOM, HL7, ISO12052, JPEG, MPEG, ISO/IEC 25051 and DIN 6878, could anyone add.
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
M Informational MHRA Guidance – Dental radiographic X-ray imaging: dose to patients Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Medical X-ray Imaging Devices guidances Medical Device and FDA Regulations and Standards News 0
M Informational USFDA draft guidance – Technical Performance Assessment of Quantitative Imaging in Device Premarket Submissions Medical Device and FDA Regulations and Standards News 0
M Medical Device News CDRH Research Programs – VICTRE: Virtual Imaging Clinical Trials for Regulatory Evaluation Medical Device and FDA Regulations and Standards News 0
I Imaging Services - Which standard should we be certified to? ISO 13485:2016 - Medical Device Quality Management Systems 4
Tagin Can/should SPC be applied to Computer Assembly and Software Imaging? Statistical Analysis Tools, Techniques and SPC 8
A Labeling MR safe & MR Unsafe (magnetic resonance imaging topic) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
CharlieUK Is Notified Body (NB) audit required for Class I imaging device ? CE Marking (Conformité Européene) / CB Scheme 20
A CE marking for a X-ray Imaging Detector CE Marking (Conformité Européene) / CB Scheme 5
Ronen E FDA distributes draft guidance related to X-ray Imaging Device 510(k)s Other US Medical Device Regulations 1
M Creating an Index for our Documents - Imaging Millions of Paper Records Document Control Systems, Procedures, Forms and Templates 13
M Software Toolkit for Medical Imaging - Need to claim conformance to EN 62304? IEC 62304 - Medical Device Software Life Cycle Processes 12
G Importing Medical Device Software to India - Diagnostic Imaging Application Other Medical Device Regulations World-Wide 8
S One function, many devices? IEC 62304 and Medical Device Imaging Software IEC 62304 - Medical Device Software Life Cycle Processes 9
B Writing a Service Plan for a new model of Imaging Camera ISO 13485:2016 - Medical Device Quality Management Systems 4
Y Preparing an audit plan for ISO 13485, MDD and CMDR for medical imaging company Imported Legacy Blogs 8
M CE Mark for Dental Imaging Software EU Medical Device Regulations 5
C USB dongle licensing system for Medical Imaging Software Other Medical Device and Orthopedic Related Topics 1
D Quality Manual and SOPs for imaging core laboratory Other ISO and International Standards and European Regulations 4
U Standards for 3-D imaging system Other ISO and International Standards and European Regulations 0
GStough What is ISO 18902? Does anyone know? Imaging Materials ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Marc Brain Scans in Hiring - Brain imaging spreads to nonmedical uses Career and Occupation Discussions 3
A Looking for UK DH Document TRS 89 - Diagnostic Imaging and Radiotherapy ISO 13485:2016 - Medical Device Quality Management Systems 2
M Where to obtain a calibrated DICOM image? ISO 13485:2016 - Medical Device Quality Management Systems 1
V Sample Size Calculation for Image Analysis - Microscopy Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
Marc New Malware Targets Facebook and Linkedin Users through Image Files Coffee Break and Water Cooler Discussions 0
A FDA guidance for MDDS, Medical Images Storage, Medical Image Communications 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
C Image Measuring System Gage R&R Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
O Minitab Script to Save Regression Plots to an Image File Using Minitab Software 8
Marc Urine Spills Staining Image of Wockhardt?s Generic Drugs Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
V Image Analysis - Particle Measurement (Characterization) - Validation - Calibration Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
W Anyone using Keyence Image Measurement System Calibration and Metrology Software and Hardware 2
Marc Naked-image full-body scanners to be taken out of U.S. airports Travel - Hotels, Motels, Planes and Trains 14
C Opposite Parts - Mirror Image FAI Requirements Inspection, Prints (Drawings), Testing, Sampling and Related Topics 11
C Mobile Medical Device for MDD - Medical Image Viewer EU Medical Device Regulations 2
C Image Viewer Classification in Australia (Software Image Processing similar to PACS) Other Medical Device Regulations World-Wide 2
Sidney Vianna Now you can use an image to start your Google search. After Work and Weekend Discussion Topics 3
Marc LIFE Photo Archive available on Google Image Search After Work and Weekend Discussion Topics 0
Manix How To Add Image Buttons for MS Access Record After Work and Weekend Discussion Topics 9
Pau Calvo Quality Management process is mandatory in ISO9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
NDesouza No Quality Professional vs Having a Quality Professional Benchmarking 24
F Does anyone have an ESD quality/cooler talk to share? Training - Internal, External, Online and Distance Learning 4
R Monitor production quality - Internal KPIs Manufacturing and Related Processes 5
U Examples of Quality Objectives for a Medtech start up ISO 13485:2016 - Medical Device Quality Management Systems 2
M SemaTech SSQA Standardized Supplier Quality Assessment - my favorite tool ever Manufacturing and Related Processes 0
D Supplier Quality level category help - high level ISO 13485:2016 - Medical Device Quality Management Systems 6
A Quality engineering positions in US - question Job Openings, Consulting and Employment Opportunities 1
R How would you work without a quality management system? IATF 16949 - Automotive Quality Systems Standard 3
P Conformity assessment based on a quality management system or production quality assurance EU Medical Device Regulations 3
H Updating Quality Manual to API Q1 Service Industry Specific Topics 4

Similar threads

Top Bottom