Usability testing
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This is s presentation about usability testing of medical devices following IEC 62366. It describes the steps that should be followed in order to comply with the process based standard. You will find a detailed documents description, testing sessions descriptions, using instruments and document templates that will get you started.
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ISO 13485:2016 is an international standard that sets out the requirements for a quality management system (QMS) specific to the medical devices industry. The standard focuses on meeting customer and applicable regulatory requirements and is intended for any organization partially or fully involved in the medical device life-cycle.
This presentation can be used to brief your employees, new hires and potential auditees so as to create awareness of the ISO 13485:2016 standard. Alternatively, the presentation may be used to supplement your materials for the training of QA professionals and internal auditors in the medical devices industry.
It covers the what and why of ISO 13485, the QMS key clause structure, the audit approach and also offers practical tips on how to handle an audit session. When you are done teaching this material to your employees, they will be much more informed and comfortable with ISO 13485:2016.
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1. Provide background knowledge on ISO 13485:2016
2. Gain an overview of ISO 13485:2016 structure and the certification process
3. Understand the audit approach
4. Gather useful tips on handling an audit session
CONTENTS
1. Overview of ISO 13485
About ISO
What are Standards?
Why are Standards Important?
What is ISO 13485?
Who is ISO 13485 For?
What is a Medical Device?
What is a Quality Management System?
How Does ISO 13485 Work?
Benefits that ISO 13485 Will Bring to the Organization
Advantages of Certification
Development of ISO 13485
Why Was ISO 13485 Revised?
Key Improvements to ISO 13485:2016
Relationship of ISO 13485 with ISO 9001
2. ISO 13485:2016 Structure
The ISO 13485:2016 Structure
The Plan-Do-Check-Act (PDCA) Process Model
ISO 13485:2016 Approach is Based on the PDCA Cycle
Documentation Requirements
ISO 13485:2016 Key Clause Structure (4-8)
Clause 4: Quality Management System
Clause 5: Management Responsibility
Clause 6: Resource Management
Clause 7: Product Realization
Clause 8: Measurement, Analysis & Improvement
3. ISO 13485:2016 Certification
Becoming ISO 13485:2016 Certified
ISO 13485:2016 Certification Process
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What Are Audits Used For?
Types of Quality Audits
Internal Quality Audit
Principles of Auditing
Audit Focus
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Audit Emphasis
Document Review
Audit Findings
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Rights of Auditee
Rights of Auditor
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ISO 13485:2016 is an international standard that sets out the requirements for a quality management system (QMS) specific to the medical devices industry. The standard focuses on meeting customer and applicable regulatory requirements and is intended for any organization partially or fully involved in the medical device life-cycle.
This presentation can be used to brief your employees, new hires and potential auditees so as to create awareness of the ISO 13485:2016 standard. Alternatively, the presentation may be used to supplement your materials for the training of QA professionals and internal auditors in the medical devices industry.
It covers the what and why of ISO 13485, the QMS key clause structure, the audit approach and also offers practical tips on how to handle an audit session. When you are done teaching this material to your employees, they will be much more informed and comfortable with ISO 13485:2016.
LEARNING OBJECTIVES
1. Provide background knowledge on ISO 13485:2016
2. Gain an overview of ISO 13485:2016 structure and the certification process
3. Understand the audit approach
4. Gather useful tips on handling an audit session
CONTENTS
1. Overview of ISO 13485
About ISO
What are Standards?
Why are Standards Important?
What is ISO 13485?
Who is ISO 13485 For?
What is a Medical Device?
What is a Quality Management System?
How Does ISO 13485 Work?
Benefits that ISO 13485 Will Bring to the Organization
Advantages of Certification
Development of ISO 13485
Why Was ISO 13485 Revised?
Key Improvements to ISO 13485:2016
Relationship of ISO 13485 with ISO 9001
2. ISO 13485:2016 Structure
The ISO 13485:2016 Structure
The Plan-Do-Check-Act (PDCA) Process Model
ISO 13485:2016 Approach is Based on the PDCA Cycle
Documentation Requirements
ISO 13485:2016 Key Clause Structure (4-8)
Clause 4: Quality Management System
Clause 5: Management Responsibility
Clause 6: Resource Management
Clause 7: Product Realization
Clause 8: Measurement, Analysis & Improvement
3. ISO 13485:2016 Certification
Becoming ISO 13485:2016 Certified
ISO 13485:2016 Certification Process
4. Audit Approach
What is a Quality Audit?
What Are Audits Used For?
Types of Quality Audits
Internal Quality Audit
Principles of Auditing
Audit Focus
Audit Approach
Audit Emphasis
Document Review
Audit Findings
5. Handling an Audit Session
Rights of Auditee
Rights of Auditor
How to Handle an Audit Session?
Auditee's Conduct
Interacting with Auditors: Do's
Interacting with Auditors: Don'tsImdrf tech-131209-samd-key-definitions-140901
This document defines key terms related to software as a medical device (SaMD). It defines SaMD as software intended for medical purposes that performs those purposes without being part of a hardware medical device. SaMD is considered a medical device. The document also defines medical purpose, SaMD changes, the SaMD manufacturer, and intended use/purpose for SaMD. It is intended to provide a common framework for regulators in their oversight of SaMD.
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Talk takeaways:
• Understanding the new requirements of PMS under MDR
• What is the impact to the business?
• How do the requirements affect your current product lifecycle approach/QMS?
• Relationship between PMCF and PMS
• What to include in your plans and reports?
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This document summarizes the objectives and classification system of the Global Harmonization Task Force (GHTF) for in vitro diagnostic (IVD) medical devices. The GHTF was founded in 1993 to harmonize medical device regulations globally. It aims to facilitate trade while preserving public health. IVD medical devices are classified into 4 risk-based classes (A to D) based on 16 general rules related to device invasiveness, energy use, and disease detection. Class A devices pose the lowest risk while Class D the highest. The classification system aims to ensure regulatory oversight is proportionate to device risk.
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This document discusses corrective and preventive action (CAPA) systems. It defines key terms like nonconformance and defines CAPA's goals of eliminating causes of non-conformities. CAPA has two functions - corrective actions to address root causes of problems, and preventive actions to prevent reoccurrence. The document outlines objectives of an effective CAPA system and provides steps to implement corrective and preventive actions, including defining problems, identifying causes, designing measures, and ensuring documentation is updated. It stresses the importance of planning, communication, and documentation for successful CAPA execution.
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This document provides guidance on applying risk management principles to determine corrective and preventive action (CAPA) decisions. It defines factors for assessing risk, including severity, frequency, and detectability. Risk scores are calculated based on these factors for both product risks and compliance risks. The document provides a risk priority number matrix and guidance on CAPA decisions based on the risk assessment.
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The document discusses the importance of documentation in software testing. It notes that documentation is needed to record test implementation and results, and helps direct testing and reuse tests. There are different types of test documentation, including test plans, specifications, and analysis reports. Effective documentation provides benefits like training, communication, maintenance, and historical reference. Test documentation should be maintained throughout the software development life cycle.
5 uncertainty of-measurements_part_i_compliance_testing
This document provides guidance for Official Medicines Control Laboratories (OMCLs) on implementing measurement uncertainty in compliance testing as required by ISO 17025. It defines key terms and outlines three approaches to estimating uncertainty - using official, marketing authorization, or internally developed methods. It states that for compliance testing, the overall uncertainty can be expressed as the relative standard deviation, as the methods have been validated and limits set based on their precision. Provided quality systems are in place, this overall approach avoids individually quantifying uncertainty components. The guidance aims to assure confidence in OMCL test results for their intended purpose of compliance testing.
Some of the Material in this paper has been repurposed from C.docx
This document provides a test plan for testing a web-based gym membership software application. It outlines the testing environment, organizational assessment, and assumptions. It discusses the importance of unit, usability, and system test planning. It describes test identification and levels including component, integration, and regression testing. It provides details on planned tests and schedules, test reports, requirements traceability, and characteristics of test plans. The test approach, outline, and regression test plan are also summarized.
D20165 award specifications_english
The document describes the standards and assessment procedures for a Level 5 module on Safety and Health at Work. It includes 22 specific learning outcomes that cover topics like workplace safety laws, hazard identification, and health promotion. Learners are assessed through two assignments worth 60% of the grade and a 1.5 hour exam worth 40%. The assignments involve investigating and evaluating aspects of safety or health, while the exam consists of short answer and structured questions testing theoretical knowledge. A pass requires earning 50-64% of total marks.
Manual Testing Interview Questions & Answers.docx
Exploratory testing is a hands-on approach where testers are involved in minimal planning and maximum test execution. The planning involves creating a test charter and objectives, while test design and execution are done in parallel without formally documenting test conditions, cases, or scripts. Some notes are taken during testing to produce a report afterwards. Use case testing identifies and executes the functional requirements of an application from start to finish using use cases. SDLC deals with software development/coding while STLC deals with validation and verification of software. A traceability matrix shows the relationship between test cases and requirements.
SMARTPHONE PRODUCTION SYSTEM
Scope of Work (SOW)
Work Breakdown Structure (WBS)
Operation Breakdown Structure (OBS)
Project Network
Standardization & digitalization of sewing operations
This document outlines a project to standardize and digitize sewing operations using lean principles. It involves analyzing current work procedures, comparing them to General Sewing Data (GSD) standards, and developing new standardized worksheets (STWs) where needed. 12 styles across 21 modules were examined. For styles with STWs, they were analyzed against GSD and improved. For styles without STWs, new ones were created from the GSD. The goal is to remove inconsistencies and optimize operations to increase productivity and quality according to lean methodology.
BSc Project Management
This document outlines the structure and contents of a typical BSc project. It discusses including an abstract, table of contents, introduction with an overview and purpose, related works, methodology, development steps, validation steps, and conclusion. The introduction provides background and problem definition. The methodology explains the research approach. Development and validation steps detail the process. References cite prior work.
Research Coupall
This document discusses the implications if product performance and specifications are not met during new product development. It begins by defining product performance and describing the typical new product development process, which consists of 5 phases: need identification and conceptual design, detail design, component development, prototype development, and production. It emphasizes the importance of establishing desired product performance based on business objectives early in the process. It also discusses how predicted and actual product performance should match the desired specifications for a new product to be successful. If performance does not meet specifications, the development process may need to iterate back to earlier phases to make changes. Overall, not meeting product specifications can result in higher costs, reduced revenue, and delays in product launch.
Static techniques
The document discusses static testing techniques, specifically reviews. It describes the review process, which typically involves 6 phases: planning, kick-off, preparation, review meeting, rework, and follow-up. Key roles in a review include the moderator, author, scribe, and reviewers. The moderator leads the process, while the author's goal is to improve the document. Reviews can find defects early and improve quality and productivity.
csc 510 Project
The document discusses improving software testing processes at XYZ Company. It begins with objectives to analyze the existing testing process, identify areas for improvement, and reduce costs. It then provides background on software testing, including definitions, the purpose of testing, and why test process improvement is needed. The document outlines steps for test process improvement, including determining goals, analyzing the current situation, and implementing changes. It reviews literature on test process improvement models, focusing on the Test Process Improvement (TPI) model as a framework with key areas, maturity levels, checkpoints, and improvement suggestions.
Malabar cements
This document provides an overview of a project report on improving equipment availability at Malabar Cements Limited in Palakkad, Kerala. It includes an introduction, literature review on previous research related to overall equipment efficiency (OEE) and total productive maintenance (TPM), profiles of the cement industry and company, objectives of the study, research methodology, findings and recommendations. The methodology section describes using tools like OEE calculation, Pareto analysis, failure mode and effect analysis, cause-effect diagrams, inventory management techniques, and control charts to analyze equipment performance and identify improvement opportunities.
BR 10 / Malé pilotní hodnocení: zpětná vazba a výsledky
The Small Pilot Evaluation - Feedback and Results
/
This report constitutes a background report to the Final report 3 – The Small Pilot Evaluation and the Use of the RD&I Information System for Evaluation. It focuses on the outcomes of the Small Pilot Evaluation (SPE) that was implemented in the context of this study from the month of September 2014 (launch of the preparatory activities) to the end of January 2015 (final panel reports).
common technical document vs electronic common technical document
This presentation deals with brief overview of common technical document and its electronic version that is implemented by three ICH regions and common format for the dossier preparation for NDA application and documents required to prepare types of modules in database in specified format as specified by regulatory authorities.
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EHS672_3.2.1_Goal-and-Scope-Definition_LCA_STUDENT.pptx
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Regulatory Affairs role in Pharmaceutical Industry
Regulatory Affairs role in Pharmaceutical Industry
5 uncertainty of-measurements_part_i_compliance_testing
5 uncertainty of-measurements_part_i_compliance_testing
Some of the Material in this paper has been repurposed from C.docx
Some of the Material in this paper has been repurposed from C.docx
Standardization & digitalization of sewing operations
Standardization & digitalization of sewing operations
BR 10 / Malé pilotní hodnocení: zpětná vazba a výsledky
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common technical document vs electronic common technical document
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Ui course
This is a presentation about what does it mean to use colors when creating user interfaces. It covers Colors Theory, Colors Psychology, Color combinations, and mobile platforms colors. At the end, there is an exercise.
UX/UI Forth Course
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Usability Testing :
UT participants
UT tasks
UT structure
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UX/UI Third Course
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Join us for an engaging session led by Flow Champion, Tom Kitt. This session will dive into a technique of enhancing the user interfaces and user experiences within Screen Flows using the Salesforce Lightning Design System (SLDS). This technique uses Native functionality, with No Apex Code, No Custom Components and No Managed Packages required.
What is Continuous Testing in DevOps - A Definitive Guide.pdf
Once an overlooked aspect, continuous testing has become indispensable for enterprises striving to accelerate application delivery and reduce business impacts. According to a Statista report, 31.3% of global enterprises have embraced continuous integration and deployment within their DevOps, signaling a pervasive trend toward hastening release cycles.
Superpower Your Apache Kafka Applications Development with Complementary Open...
Kafka Summit talk (Bangalore, India, May 2, 2024, https://events.bizzabo.com/573863/agenda/session/1300469 )
Many Apache Kafka use cases take advantage of Kafka’s ability to integrate multiple heterogeneous systems for stream processing and real-time machine learning scenarios. But Kafka also exists in a rich ecosystem of related but complementary stream processing technologies and tools, particularly from the open-source community. In this talk, we’ll take you on a tour of a selection of complementary tools that can make Kafka even more powerful. We’ll focus on tools for stream processing and querying, streaming machine learning, stream visibility and observation, stream meta-data, stream visualisation, stream development including testing and the use of Generative AI and LLMs, and stream performance and scalability. By the end you will have a good idea of the types of Kafka “superhero” tools that exist, which are my favourites (and what superpowers they have), and how they combine to save your Kafka applications development universe from swamploads of data stagnation monsters!
Penify - Let AI do the Documentation, you write the Code.
Penify automates the software documentation process for Git repositories. Every time a code modification is merged into "main", Penify uses a Large Language Model to generate documentation for the updated code. This automation covers multiple documentation layers, including InCode Documentation, API Documentation, Architectural Documentation, and PR documentation, each designed to improve different aspects of the development process. By taking over the entire documentation process, Penify tackles the common problem of documentation becoming outdated as the code evolves.
https://www.penify.dev/
The Rising Future of CPaaS in the Middle East 2024
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All you need to know about Spring Boot and GraalVM
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Modelling Up - DDDEurope 2024 - Amsterdam
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This talk explores the challenges of bringing modelling rigour to the business and strategy levels, and talking to your non-technical counterparts in the process.
Streamlining End-to-End Testing Automation
Streamlining End-to-End Testing Automation with Azure DevOps Build & Release Pipelines
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Challenge #1. Ensuring Test Environment Consistency: Establishing a standardized test execution environment across hundreds of Azure DevOps agents is crucial for achieving dependable testing results. This uniformity must seamlessly span from Build pipelines to various stages of the Release pipeline.
Challenge #2. Coordinated Test Execution Across Environments: Executing distinct subsets of tests using the same automation framework across diverse environments, such as the build pipeline and specific stages of the Release Pipeline, demands flexible and cohesive approaches.
Challenge #3. Testing on Linux-based Azure DevOps Agents: Conducting tests, particularly for web and native apps, on Azure DevOps Linux agents lacking browser or device connectivity presents specific challenges in attaining thorough testing coverage.
This session delves into how these challenges were addressed through:
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2. Create standardized templates for executing API tests, API workflow tests, and end-to-end tests in the Build pipeline, streamlining the testing process.
3. Implement task groups in Release pipeline stages to facilitate the execution of tests, ensuring consistency and efficiency across deployment phases.
4. Deploy browsers within Docker containers for web application testing, enhancing portability and scalability of testing environments.
5. Leverage diverse device farms dedicated to Android, iOS, and browser testing to cover a wide range of platforms and devices.
6. Integrate AI technology, such as Applitools Visual AI and Ultrafast Grid, to automate test execution and validation, improving accuracy and efficiency.
7. Utilize AI/ML-powered central test automation reporting server through platforms like reportportal.io, providing consolidated and real-time insights into test performance and issues.
These solutions not only facilitate comprehensive testing across platforms but also promote the principles of shift-left testing, enabling early feedback, implementing quality gates, and ensuring repeatability. By adopting these techniques, teams can effectively automate and execute tests, accelerating software delivery while upholding high-quality standards across Android, iOS, and web applications.
一比一原版(sdsu毕业证书)圣地亚哥州立大学毕业证如何办理
原版一模一样【微信：741003700 】【(sdsu毕业证书)圣地亚哥州立大学毕业证成绩单】【微信：741003700 】学位证，留信认证（真实可查，永久存档）原件一模一样纸张工艺/offer、雅思、外壳等材料/诚信可靠,可直接看成品样本，帮您解决无法毕业带来的各种难题！外壳，原版制作，诚信可靠，可直接看成品样本。行业标杆！精益求精，诚心合作，真诚制作！多年品质 ,按需精细制作，24小时接单,全套进口原装设备。十五年致力于帮助留学生解决难题，包您满意。
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◇在校期间，因各种原因未能顺利毕业……拿不到官方毕业证【q/微741003700】
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留信网认证的作用:
1:该专业认证可证明留学生真实身份
2:同时对留学生所学专业登记给予评定
3:国家专业人才认证中心颁发入库证书
4:这个认证书并且可以归档倒地方
5:凡事获得留信网入网的信息将会逐步更新到个人身份内，将在公安局网内查询个人身份证信息后，同步读取人才网入库信息
6:个人职称评审加20分
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办理(sdsu毕业证书)圣地亚哥州立大学毕业证【微信：741003700 】外观非常简单，由纸质材料制成，上面印有校徽、校名、毕业生姓名、专业等信息。
办理(sdsu毕业证书)圣地亚哥州立大学毕业证【微信：741003700 】格式相对统一，各专业都有相应的模板。通常包括以下部分：
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校名:学校英文全称
授予学位：本部分将注明获得的具体学位名称。
毕业生姓名：这是最重要的信息之一，标志着该证书是由特定人员获得的。
颁发日期：这是毕业正式生效的时间，也代表着毕业生学业的结束。
其他信息：根据不同的专业和学位，可能会有一些特定的信息或章节。
办理(sdsu毕业证书)圣地亚哥州立大学毕业证【微信：741003700 】价值很高，需要妥善保管。一般来说，应放置在安全、干燥、防潮的地方，避免长时间暴露在阳光下。如需使用，最好使用复印件而不是原件，以免丢失。
综上所述，办理(sdsu毕业证书)圣地亚哥州立大学毕业证【微信：741003700 】是证明身份和学历的高价值文件。外观简单庄重，格式统一，包括重要的个人信息和发布日期。对持有人来说，妥善保管是非常重要的。
Stork Product Overview: An AI-Powered Autonomous Delivery Fleet
Imagine a world where instead of blue and brown trucks dropping parcels on our porches, a buzzing drove of drones delivered our goods. Now imagine those drones are controlled by 3 purpose-built AI designed to ensure all packages were delivered as quickly and as economically as possible That's what Stork is all about.
WMF 2024 - Unlocking the Future of Data Powering Next-Gen AI with Vector Data...
Vector databases are transforming how we handle data, allowing us to search through text, images, and audio by converting them into vectors. Today, we'll dive into the basics of this exciting technology and discuss its potential to revolutionize our next-generation AI applications. We'll examine typical uses for these databases and the essential tools
developers need. Plus, we'll zoom in on the advanced capabilities of vector search and semantic caching in Java, showcasing these through a live demo with Redis libraries. Get ready to see how these powerful tools can change the game!
一比一原版(UMN毕业证)明尼苏达大学毕业证如何办理
UMN硕士毕业证成绩单【微信95270640】购买（明尼苏达大学毕业证成绩单硕士学历）Q微信95270640代办UMN学历认证留信网伪造明尼苏达大学学位证书精仿明尼苏达大学本科/硕士文凭证书补办明尼苏达大学 diplomaoffer,Transcript购买明尼苏达大学毕业证成绩单购买UMN假毕业证学位证书购买伪造明尼苏达大学文凭证书学位证书,专业办理雅思、托福成绩单，学生ID卡，在读证明，海外各大学offer录取通知书，毕业证书，成绩单，文凭等材料:1:1完美还原毕业证、offer录取通知书、学生卡等各种在读或毕业材料的防伪工艺（包括 烫金、烫银、钢印、底纹、凹凸版、水印、防伪光标、热敏防伪、文字图案浮雕，激光镭射，紫外荧光，温感光标）学校原版上有的工艺我们一样不会少，不论是老版本还是最新版本，都能保证最高程度还原，力争完美以求让所有同学都能享受到完美的品质服务。
#毕业证成绩单 #毕业証 #成绩单 #學生卡 #OFFER录取通知书 #雅思#托福等……
国外大学明尼苏达大学明尼苏达大学毕业证offer制作方法（一对一专业服务）
1客户提供办理信息：姓名生日专业学位毕业时间等（如信息不确定可以咨询顾问：我们有专业老师帮你查询）；
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此贴长年有效【贴心专线/微-信: 95270640】敬请保留此联系方式以备用！如有不在线请给我们留言！我们将在第一时间给您回复!上散发着一抹抹的光晕而这每处自然形成的细节融合在一起浑然天成的美实在令人心生愉悦小道的周边无秩序的生长着几株艳丽的野花红的粉的紫的虽混乱无章却给这幅美景更增添一份性感夹杂着一份纯洁的妖娆毫无违和感实在给人带来一份悠然幸福的心情如果说现在的审美已经断然拒绝了无声的话那么在树林间飞掠而过的小鸟叽叽咋咋的叫声是否就是这最后的点睛之笔悠然走在林间的小路上宁静与清香一丝丝的盛夏气息吸入身体昔日生活里的繁忙多
Why Apache Kafka Clusters Are Like Galaxies (And Other Cosmic Kafka Quandarie...
Closing talk for the Performance Engineering track at Community Over Code EU (Bratislava, Slovakia, June 5 2024) https://eu.communityovercode.org/sessions/2024/why-apache-kafka-clusters-are-like-galaxies-and-other-cosmic-kafka-quandaries-explored/ Instaclustr (now part of NetApp) manages 100s of Apache Kafka clusters of many different sizes, for a variety of use cases and customers. For the last 7 years I’ve been focused outwardly on exploring Kafka application development challenges, but recently I decided to look inward and see what I could discover about the performance, scalability and resource characteristics of the Kafka clusters themselves. Using a suite of Performance Engineering techniques, I will reveal some surprising discoveries about cosmic Kafka mysteries in our data centres, related to: cluster sizes and distribution (using Zipf’s Law), horizontal vs. vertical scalability, and predicting Kafka performance using metrics, modelling and regression techniques. These insights are relevant to Kafka developers and operators.
Ensuring Efficiency and Speed with Practical Solutions for Clinical Operations
Clinical operations professionals encounter unique challenges. Balancing regulatory requirements, tight timelines, and the need for cross-functional collaboration can create significant internal pressures. Our upcoming webinar will introduce key strategies and tools to streamline and enhance clinical development processes, helping you overcome these challenges.
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Photoshop Tutorial for Beginners (2024 Edition)
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Explore the evolution of programming and software development and design in 2024. Discover emerging trends shaping the future of coding in our insightful analysis."
Here's an overview:Introduction: The Evolution of Programming and Software DevelopmentThe Rise of Artificial Intelligence and Machine Learning in CodingAdopting Low-Code and No-Code PlatformsQuantum Computing: Entering the Software Development MainstreamIntegration of DevOps with Machine Learning: MLOpsAdvancements in Cybersecurity PracticesThe Growth of Edge ComputingEmerging Programming Languages and FrameworksSoftware Development Ethics and AI RegulationSustainability in Software EngineeringThe Future Workforce: Remote and Distributed TeamsConclusion: Adapting to the Changing Software Development LandscapeIntroduction: The Evolution of Programming and Software Development
Photoshop Tutorial for Beginners (2024 Edition)Explore the evolution of programming and software development and design in 2024. Discover emerging trends shaping the future of coding in our insightful analysis."Here's an overview:Introduction: The Evolution of Programming and Software DevelopmentThe Rise of Artificial Intelligence and Machine Learning in CodingAdopting Low-Code and No-Code PlatformsQuantum Computing: Entering the Software Development MainstreamIntegration of DevOps with Machine Learning: MLOpsAdvancements in Cybersecurity PracticesThe Growth of Edge ComputingEmerging Programming Languages and FrameworksSoftware Development Ethics and AI RegulationSustainability in Software EngineeringThe Future Workforce: Remote and Distributed TeamsConclusion: Adapting to the Changing Software Development LandscapeIntroduction: The Evolution of Programming and Software Development
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Course objectives:
1. **Learn about the basics of software development:
- Understanding software development processes and tools.
- Identify the role of programmers and designers in software projects.
2. Understanding the software design process:
- Learn about the principles of good software design.
- Discussing common design patterns such as Object-Oriented Design.
3. The importance of user experience (UX) in modern software:
- Explore how user experience can improve software acceptance and usability.
- Tools and techniques to analyze and improve user experience.
4. Increase efficiency and productivity through modern development tools:
- Access to the latest programming tools and languages used in the industry.
- Study live examples of applications
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Usability testing
- 1. Usability Testing This is a presentation about Usability Testing of Medical Devices following IEC - 62366
- 2. 1.Usability testing IEC - 62366 is a process based standard which specifies usability requirements for medical devices development. P PLANNING T TESTING A ANALYZING M MEASURING
- 3. 2.General information In order to develop a medical device, you need to follow the process based standard that complies with regulatory requirements from USA and EU markets. IEC-62366
- 4. 3.Planning process How do we prepare the test? According to IEC - 62366 medical device regulation we need to document the usability plans. Formative Usability Evaluation Plan Summative Usability Evaluation Plan General Usability Evaluation Plan
- 5. 3.1 General Usability Evaluation Plan 2. Methodology 3. Roles 4. Usability tasks 5. Usability metrics 1. Document overview GUEP is a document that represents the high-level details of the testing plan. It should contain the following chapters: 6. Usability goals
- 6. 3.2 Formative Usability Evaluation Plan FUEP is a more detailed document that aims to form the design of the product. The document should contain the following chapters: 2. Product description 3. Description of the participants 4. Evaluation methodology 5. Objectives 1. Facilitators and observers 6. Session introduction 7. Screening questions 8. Test scenario 9. Exceptions 10. Tasks structure 11. Survey form 12. Incentives
- 7. 3.3 Summative Usability Evaluation Plan SUEP document helps to benchmark the product to the original requirements. The document should contain the following chapters: 2. Product description 3. Description of the participants 4. Evaluation methodology 5. Objectives 1. Facilitators and observers 6. Session introduction 7. Screening questions 8. Test scenario 9. Exceptions 10. Tasks structure 11. Survey form 12. Incentives
- 8. 4. Session description 1. Smartphone 2. Notepad and a pen 3. Laptop 4. Recording device and a camera A complete testing session should last not more than 50 min. It can take place in a quiet and comfortable place. The session instruments could be:
- 9. 5. Results analysis General Usability Test Report Formative Usability Evaluation Report Summative Usability Evaluation Report After all, the testing sessions were completed and everything was registered and written down the outcome can be summarized in the following documents:
- 10. 5.1 General Usability Evaluation Report GUER summarizes what happened during the implementation of the usability testing in the chapters below: 2. Methodology 3. Results 4. Recommendations 5. Conclusion 1. Document summary
- 11. 5.2 Formative Usability Test Report In FUTR document the deviations and findings can be reflected in the following chapters: 2. Findings 3. Deviations 4. Tests results 5. Analysis results 1. Document overview 6. Conclusion
- 12. 5.3 Summative Usability Test Report SUTR follows the same structure as the previous document and addresses the findings from the updated product in the following chapters: 2. Findings 3. Deviations 4. Tests results 5. Analysis results 1. Document overview 6. Conclusion
- 13. 6. Measuring results 25 Worst 38 Poor 52 OK 72 Good 85 Excellent 95 Best After completing the survey we need to count the points from each participant and the result should be multiplied by 2.5. The final number can be placed on the following scale.
- 14. 7. Takeaways Usability Evaluation Plan https://www.usability.gov/how-to-and-tools/ methods/planning-usability-testing.html Usability Evaluation Report https://www.usability.gov/how-to-and-tools/ resources/templates/report-template- usability-test.html SUS https://www.measuringux.com/SUS.ppt