№ files_lp_4_process_1_29816
File format: docx
Character count: 10561
File size: 16 KB
Year:
2026
Document Type:
Standard Operating Procedure
Scope:
Software as a Medical Device Development
Standards Referenced:
IEC 62304:2006, ISO 14971:2019, IEC 62366-1:2015
Departments Involved:
CEO, CTO, CPO, Software Engineers, Usability Engineers, Risk Managers, Subject Matter Experts
Process Steps:
Design Input, Usability Engineering and Risk Management Planning, First Risk and Usability Assessment, Software Planning, Software Planning Review, Software Architecture, Detailed Design and Implementation
Outputs:
Device Description, Vision Document, Software Requirements, Software System Test Plan, Risk Table, Risk Management Plan, Usability Evaluation Plan, Usage Scenarios, Software Safety Classification
Audience:
Development teams in medical device software
Context:
SOP document detailing procedures for developing medical device software integrating risk management and usability engineering, following IEC and ISO standards.
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2007
Region / City:
Florida, Tallahassee
Topic:
Environmental Data Quality Assessment
Document Type:
Process/Guideline
Organization:
Florida Department of Environmental Protection
Author:
Florida Department of Environmental Protection
Target Audience:
Environmental data auditors, environmental scientists
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Modifications:
Not specified
Year:
2024
Region / city:
N/A
Topic:
Environmental Data Usability Assessment
Document Type:
Template
Organization / institution:
N/A
Author:
N/A
Target Audience:
Environmental project managers, quality assurance officers, and data users
Period of validity:
N/A
Approval date:
N/A
Modification date:
N/A
Note:
Year
Subject:
Voting Systems Testing, Usability, Election Workers
Document Type:
Guidelines
Organization:
National Institute of Standards and Technology (NIST)
Target Audience:
Election system manufacturers, election workers, usability testers
Year:
2023
Region / City:
United States
Topic:
Usability testing of voting systems
Document Type:
Template
Organization / Institution:
National Institute of Standards and Technology (NIST)
Author:
NIST Voting Program
Target Audience:
Voting manufacturers, usability test administrators
Period of Validity:
Ongoing
Approval Date:
2023-02-01
Modification Date:
N/A
Year:
2020
Region / city:
Global
Topic:
Education Technology, Learning Design
Document type:
Chapter
Organization:
Not specified
Author:
Jahnke, I., Schmidt, M., Pham, M., Singh, K.
Target audience:
Researchers, instructional designers, learning designers
Period of validity:
Ongoing
Date of approval:
Not specified
Date of changes:
Not specified
Document type:
Examination questions
Format:
Multiple-choice questions and answers
Subject area:
Human-Computer Interaction (HCI)
Topics covered:
Usability, User Interface Design, Ergonomics, Internet History, Computing History, Perception, Human Information Processing
Referenced standards:
ISO 9241
Referenced organisations:
International Standards Organisation (ISO), CERN, NCSA National Centre for Super Computer Applications
Referenced individuals:
Herman Hollerith, Charles Babbage
Examination sessions:
Oct/Nov 2011; May/June 2011; 201/1/2012; 201/2/2012; Oct/Nov 2012; Oct/Nov 2013; May/June 2014; Oct/Nov 2014; May/June 2015; Oct/Nov 2015; 201/1/2016; 201/2/2016; May/June 2017; Oct/Nov 2017; 203/1/2018
Educational level:
Tertiary education
Language:
English
Year:
2018
Note:
Region / City
Topic:
Mobile health apps, Usability, Proficiency measures
Document Type:
Research article
Author:
Roque, N. A., Boot, W. R., Boot W.R., Charness N., Czaja S.J., Stoyanov, S. R., Hides, L., Sauro, J., Larsen, D. L., Attkisson, C. C., Hargreaves, W. A., Nguyen, T. D., Berry, K., Salter, A., Morris, R., James, S., Bucci, S.
Target Audience:
Researchers, developers of mHealth apps, healthcare professionals
Year:
2022
Region / city:
United States
Topic:
Early hearing detection and intervention
Document type:
Evaluation report
Agency / institution:
CDC (Centers for Disease Control and Prevention)
Authors:
Maria Sanchez, Kelly [Last name not provided]
Target audience:
Healthcare professionals, EHDI program staff, policymakers
Period of validity:
2021-2022
Approval date:
March 2022
Date of changes:
N/A
Document title:
Attachment B – Usability Testing Script for CCSM CDS Interface
Subject:
Cervical Cancer Screening and Management Clinical Decision Support (CCSM CDS) Dashboard
Type of document:
Usability testing script
Project:
CCSM CDS Dashboard development and pilot
Format:
Interview and task-based evaluation guide
Platform:
Web application launched from an electronic health record system
Interview method:
Microsoft Teams recorded session
Evaluation duration:
Approximately one hour
Participants:
Usability test volunteers / clinicians
Conducted by:
Lead evaluator and usability team member
Purpose:
Collection of user feedback on interface design, functionality, and clinical recommendation display
Scope:
Patient information display, medical history review, CDS recommendation review, risk table interpretation, and general feedback
Year:
2016
Region / city:
United States
Subject:
Usability evaluation, application development
Document type:
Evaluation plan
Organization:
U.S. Census Bureau
Author:
HFUR/CSM and CEDSCI/Decennial Sponsors
Target audience:
Application development teams, usability evaluators, U.S. Census Bureau
Period of validity:
October 1, 2016 - September 30, 2017
Approval date:
September 10, 2016
Revision date:
October 31, 2016
Year:
2016
Country:
United States
Agency:
U.S. General Services Administration
Website:
USA.gov
Document Type:
Consent form and usability testing protocol
OMB Control Number:
3090-0297
Expiration Date:
06/30/2016
Legal Basis:
Paperwork Reduction Act of 1995 (44 U.S.C. § 3507)
Purpose:
Collection of participant feedback for website evaluation and improvement
Data Collection Methods:
Audio recording, video recording, interaction tracking
Estimated Time Burden:
One hour session; one minute to read and answer required questions
Contact Address:
General Services Administration, Regulatory Secretariat (MVCB), 1800 F Street, NW, Washington, DC 20405
Intended Participants:
Usability test participants providing feedback on USA.gov
Topics Covered:
Homepage impressions, feature navigation, mortgage assistance search, app downloads, language switching, email sign-up, social media access, contact information, search functionality
Year:
2017
Region / City:
United States
Subject:
Usability testing of NAPCS product search interface
Document Type:
Research protocol / interview guide
Organization / Institution:
U.S. Census Bureau
Author:
Census Bureau Research Team
Target Audience:
Company employees responding to the 2017 Economic Census
Methodology:
Audio-recorded usability interviews
Data Collection Period:
2017 pre-census testing phase
Instruments:
Draft online interface screens, pre-printed question forms, error sheets, ASQ (After-Scenario Questionnaire)
Topics Covered:
Product listing usability, search function evaluation, task success, user satisfaction
Confidentiality Measures:
Consent form signed prior to recording
Interview Structure:
Introduction, background questions, instrument walk-through, probes, follow-up questions, general questions
Year:
2021
Region / City:
United States
Topic:
Usability Testing, Data Collection
Document Type:
Statement
Author:
Health Resources and Services Administration (HRSA)
Target Audience:
Healthcare practitioners, regulatory bodies, NPDB users
Period of Effectiveness:
Until 07/31/2021
Approval Date:
N/A
Modification Date:
N/A
Year:
Recent
Field:
Human-Computer Interaction / Usability
Document type:
Study guide / Question list
Topics covered:
Accessibility, memory, visual and auditory systems, sensory receptors, interface design, domain analysis, testing methods, statistical analysis
Intended audience:
Students and practitioners in HCI and UX
Key concepts:
Primary and secondary users, long-term memory, sensory systems, Fitts’s Law, GOMS, KLM, Schneiderman’s rules, WCAG
Methodologies:
Heuristic evaluation, usability metrics, iterative testing, controlled studies, statistical inference
Year:
2026
Region / City:
United States (multiple cities)
Subject:
Usability testing, home energy surveys
Document Type:
Recruitment advertisement
Organization / Institution:
RTI International
Target Audience:
Adults with smartphones, apartment residents, electric vehicle owners
Compensation:
$50 Visa gift card
Participation Mode:
Remote via Zoom
Survey Topic:
Home energy consumption
Language Versions:
English, Spanish
OMB Control Number:
1905-0186
Expiration Date:
TBD
Year:
2020
Region / City:
Florida
Topic:
Field Testing, Field Sampling, Environmental Monitoring
Document Type:
Standard Operating Procedures (SOP)
Organization / Institution:
Florida Department of Environmental Protection (FDEP)
Author:
Not specified
Target Audience:
Field technicians, environmental scientists, laboratories
Effective Period:
Ongoing
Approval Date:
Not specified
Date of Changes:
2020
Note:
Year
Topic:
Household Hazardous Waste, Battery Management, Safety
Document Type:
Standard Operating Procedure
Agency / Institution:
MPCA (Minnesota Pollution Control Agency)
Target Audience:
Household Hazardous Waste Program Staff, Facility Managers
MMU Human Tissue Act Document Control Standard Operating Procedure (SOP), Version 1.2, February 2025
Institution:
Manchester Metropolitan University
Regulatory framework:
Human Tissue Act 2004
Document type:
Standard Operating Procedure
SOP number:
MMUHTA_017
Version:
1.2
Effective date:
February 2025
Review due date:
February 2027
Superseded version:
1.1
Superseded version date:
3 March 2023
Author:
Jake Pogson
Author role:
Person Designated
Author date:
18 July 2024
Reviewer:
Garry Pheasey
Reviewer role:
Person Designated
Reviewer date:
24 February 2025
Approver:
Hans Degens
Approver role:
Designated Individual
Approval date:
28 February 2025
Read groups:
Staff, Visitors, Students and Participants
Scope:
Manchester Metropolitan University staff involved in work with relevant material
Subject area:
Human tissue governance and document control
Associated documents:
HTA Codes of Practice and Standards
Period covered by changes:
2023–2025
Note:
Year
Note:
Year
Contextual description of the document:
Instructions for reviewing, updating, and printing a Standard Operating Procedure (SOP) document for safety and operational guidelines regarding the use of machinery.