When created early in the product development lifecycle, a trace matrix can do more than just help you gain FDA approval for your device. Unfortunately, many companies create the matrix sporadically during a project, mainly right before regulatory submission—too late to capture the benefits a well-maintained matrix can deliver.
During this recorded webinar, guest speaker Steve Rakitin, President of Software Quality Consulting, discussed five of the benefits gained by maintaining a matrix throughout the project. A software engineer with more than 20 years of experience in the medical device industry, Steve explains how a trace matrix can help you:
- Plan and estimate testing and validation needs
- Ensure all requirements are implemented
- Verify that all requirements have been tested
- Manage change throughout product development
- Provide evidence that hazard mitigations are implemented and validated
With new technologies come many innovative medical devices and tools to help treat patients and to improve their quality of life thru diagnosis, monitoring and therapy. New fields of study within Engineering are emerging throughout the academic community to better understand and improve these devices and tools. As a Systems Engineer what are we doing in this application that’s different from others? What are the challenges? What do we need to improve on? And Why?
This presentation provides an overview of the different types of Medical Devices and addresses the associated implications that affect the system under design. An example of a specific Medical Device will be presented along with a description of how the system integrates with Biological component. Systems Engineering Process comparison between Medical Device industry and Defense industry where Systems Engineering was conceived has been integrated throughout this presentation. You will learn more about some of the challenges that Medical Devices industry is facing and potential Systems Engineering solutions with specific approach and methodology.
How User Experience Design and Human Factors Engineering can Accelerate Produ...Greenlight Guru
A growing number of medtech companies are embracing User Experience (UX) Design and Human Factors Engineering (HFE) — not just to meet FDA regulations, but also to create more intuitive, more usable, and holistically better products. These practices required to promote safety and efficacy also provide an opportunity for your company to quickly deliver products that are more innovative, which can be a key differentiator in the competitive medical device market.
This session will answer the questions: what is Human Factors Engineering and why is it important? We’ll also cover:
• Human Factors guidance and regulations
• Human Factors Engineering process overview
• Differences between regulatory usability and UX
• How to use UX to feed regulatory development
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
General Principals Of Software Validationstaciemarotta
This guidance outlines general validation principles that the Food and Drug Administration (FDA)
considers to be applicable to the validation of medical device software or the validation of software
used to design, develop, or manufacture medical devices. This final guidance document, Version 2.0,
supersedes the draft document, General Principles of Software Validation, Version 1.1, dated June
9, 1997.
Slides presented at "Getting Your Medical Device FDA Approved" event, presented by Mentor Graphics Embedded Software, discussing how to address the enhanced scrutiny from government agencies that can introduce significant delays with the commercial release of software-related medical devices.
Getting through the FDA review as quickly as possible requires a clear understanding of the development standards, documentation and testing that is now expected for Medical devices. During this session we discussed how FDA hot buttons affect your medical device submission will be discussed, including:
-Requirements for software development as outlined in IEC 62304
-Content considerations for premarket submissions
-Human factors engineering as a platform for enhanced user safety
-Provisions for data security and protection against unauthorized wireless access
We reviewed the design control requirements and product development approach that can shorten your medical device's path to market with a focus on safety, human factors engineering and security.
With new technologies come many innovative medical devices and tools to help treat patients and to improve their quality of life thru diagnosis, monitoring and therapy. New fields of study within Engineering are emerging throughout the academic community to better understand and improve these devices and tools. As a Systems Engineer what are we doing in this application that’s different from others? What are the challenges? What do we need to improve on? And Why?
This presentation provides an overview of the different types of Medical Devices and addresses the associated implications that affect the system under design. An example of a specific Medical Device will be presented along with a description of how the system integrates with Biological component. Systems Engineering Process comparison between Medical Device industry and Defense industry where Systems Engineering was conceived has been integrated throughout this presentation. You will learn more about some of the challenges that Medical Devices industry is facing and potential Systems Engineering solutions with specific approach and methodology.
How User Experience Design and Human Factors Engineering can Accelerate Produ...Greenlight Guru
A growing number of medtech companies are embracing User Experience (UX) Design and Human Factors Engineering (HFE) — not just to meet FDA regulations, but also to create more intuitive, more usable, and holistically better products. These practices required to promote safety and efficacy also provide an opportunity for your company to quickly deliver products that are more innovative, which can be a key differentiator in the competitive medical device market.
This session will answer the questions: what is Human Factors Engineering and why is it important? We’ll also cover:
• Human Factors guidance and regulations
• Human Factors Engineering process overview
• Differences between regulatory usability and UX
• How to use UX to feed regulatory development
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
General Principals Of Software Validationstaciemarotta
This guidance outlines general validation principles that the Food and Drug Administration (FDA)
considers to be applicable to the validation of medical device software or the validation of software
used to design, develop, or manufacture medical devices. This final guidance document, Version 2.0,
supersedes the draft document, General Principles of Software Validation, Version 1.1, dated June
9, 1997.
Slides presented at "Getting Your Medical Device FDA Approved" event, presented by Mentor Graphics Embedded Software, discussing how to address the enhanced scrutiny from government agencies that can introduce significant delays with the commercial release of software-related medical devices.
Getting through the FDA review as quickly as possible requires a clear understanding of the development standards, documentation and testing that is now expected for Medical devices. During this session we discussed how FDA hot buttons affect your medical device submission will be discussed, including:
-Requirements for software development as outlined in IEC 62304
-Content considerations for premarket submissions
-Human factors engineering as a platform for enhanced user safety
-Provisions for data security and protection against unauthorized wireless access
We reviewed the design control requirements and product development approach that can shorten your medical device's path to market with a focus on safety, human factors engineering and security.
FDA Regulations and Medical Device Pathways to MarketMethodSense, Inc.
Bringing your medical device to market requires in-depth attention to its safety, reliability and compliance. In addition to designing a quality medical device, it’s critical that you anticipate and address the requirements that allow you to introduce it to the market successfully.
Life Science consulting firm, MethodSense, discusses important FDA regulations as they relate to bringing a medical device to market, including 21 CFR Part 821, 510(k) approval and 21 CFR Part 11.
CODEX Validation Group is a consulting company with broad experience in the cGMP, compliance, automation, and validation for the Pharmaceutical, Biotechnology and Medical Device industries committed to follow the highest ethical standards as we work with our customers.
This presentation was delivered as a webinar for FDAnews, delving into software, medical devices and managing risk with 21 CFR Part 11 and IEC 62304. It provides:
• A historical backdrop of IEC 62304
• An overview of IEC 62304
• Implementing IEC 62304
• Common pitfalls to avoid
Presentation describes the importance of IT validation from the perspectives of the FDA and our company. It explains GAMP 5, the Validation Life Cycle, good documentation practices, document naming conventions, Change Control, Problem Management, Periodic Evaluation, FDA 483 Warning Letters and 21 CFR Part 11 and a unique Validation Life Cycle.
Process and Regulated Processes Software Validation ElementsArta Doci
Medical device manufacturers operate in a competitive marketplace with increasing end-user demands for features and usability and in a highly regulated environment.
Regulatory bodies look for evidence that medical devices are developed under a structured, quality-oriented development process. By following software validation and verification best practices, one can not only increase the likelihood that they will meet their compliance goals, they can also enhance developer productivity.
IEC 62304 is the international standard that defines software development lifecycle requirements for medical device software. The standard was developed from the perspective that product testing alone is insufficient to ensure patient safety when software is involved. The standard requires all aspects of the software development life cycle to be scrutinized.
Prepare your medical device for market with this Action List that walks you through the complexities of IEC 62304
Medical Device Concessions - EduQuest AdvisoryEduQuest, Inc.
Are medical device companies releasing too many products "on concession" while overlooking core quality problems? EduQuest has published an Advisory on FDA expectations for concessions and how they relate to the ISO rules for a concession. For details, contact Info@EduQuest.net
An introduction to Life Sciences Computer System Validation, applicable regulation, SDLC phases, software categorisation, risk/ change/ deviation management, validation deliverable, risk based approach, regulatory inspection, audit findings, causes of compliance failure, key concepts in CSV etc.
FDA Regulations and Medical Device Pathways to MarketMethodSense, Inc.
Bringing your medical device to market requires in-depth attention to its safety, reliability and compliance. In addition to designing a quality medical device, it’s critical that you anticipate and address the requirements that allow you to introduce it to the market successfully.
Life Science consulting firm, MethodSense, discusses important FDA regulations as they relate to bringing a medical device to market, including 21 CFR Part 821, 510(k) approval and 21 CFR Part 11.
CODEX Validation Group is a consulting company with broad experience in the cGMP, compliance, automation, and validation for the Pharmaceutical, Biotechnology and Medical Device industries committed to follow the highest ethical standards as we work with our customers.
This presentation was delivered as a webinar for FDAnews, delving into software, medical devices and managing risk with 21 CFR Part 11 and IEC 62304. It provides:
• A historical backdrop of IEC 62304
• An overview of IEC 62304
• Implementing IEC 62304
• Common pitfalls to avoid
Presentation describes the importance of IT validation from the perspectives of the FDA and our company. It explains GAMP 5, the Validation Life Cycle, good documentation practices, document naming conventions, Change Control, Problem Management, Periodic Evaluation, FDA 483 Warning Letters and 21 CFR Part 11 and a unique Validation Life Cycle.
Process and Regulated Processes Software Validation ElementsArta Doci
Medical device manufacturers operate in a competitive marketplace with increasing end-user demands for features and usability and in a highly regulated environment.
Regulatory bodies look for evidence that medical devices are developed under a structured, quality-oriented development process. By following software validation and verification best practices, one can not only increase the likelihood that they will meet their compliance goals, they can also enhance developer productivity.
IEC 62304 is the international standard that defines software development lifecycle requirements for medical device software. The standard was developed from the perspective that product testing alone is insufficient to ensure patient safety when software is involved. The standard requires all aspects of the software development life cycle to be scrutinized.
Prepare your medical device for market with this Action List that walks you through the complexities of IEC 62304
Medical Device Concessions - EduQuest AdvisoryEduQuest, Inc.
Are medical device companies releasing too many products "on concession" while overlooking core quality problems? EduQuest has published an Advisory on FDA expectations for concessions and how they relate to the ISO rules for a concession. For details, contact Info@EduQuest.net
An introduction to Life Sciences Computer System Validation, applicable regulation, SDLC phases, software categorisation, risk/ change/ deviation management, validation deliverable, risk based approach, regulatory inspection, audit findings, causes of compliance failure, key concepts in CSV etc.
Embedded software validation best practices with NI and RQMPaul Urban
Embedded control software is growing exponentially in mechanical systems, which forces test methods to evolve even faster. This presentation was part of the Rational Quality Manager enlightenment series describing how National Instruments and IBM provide end-to-end traceability and test component reuse for superior system quality and validation by enabling consistent testing, results analysis, and traceability throughout the development process.
How To Avoid Continuously Delivering Faulty SoftwareErika Barron
As organizations continue to compress development and delivery lifecycles, the risk of regressions, integration errors, and other defects rises. But how can development teams integrate defect prevention strategies into their release cycles to ensure that they're not continuously delivering faulty software? In this presentation, learn the key development testing processes to add to your Continuous Delivery system to reduce the risk of automating the release of software defects.
These are slides from local security chapters meetup, Here I tried to explain the challenges in appsec and complete framework for different life cycle of secure software development cycle
When Medical Device Software Fails Due to Improper Verification & Validation ...Sterling Medical Devices
Verification and validation are critical components in the development life cycle of any software and the results of the V & V process are imperative to the safety of the medical device.
In systems engineering and software engineering, requirements analysis encompasses those tasks that go into determining the needs or conditions to meet for a new or altered product or project, taking account of the possibly conflicting requirements of the various stakeholders, analyzing, documenting, validating and managing software or system requirements.
Breaking the Barriers to Agile Adoption in Safety- and Quality-Critical Envir...Seapine Software
Is your organization reluctant to join the Agile revolution—perceiving significant and insurmountable barriers to adoption, despite the potential benefits? Do you continue to use Microsoft Office—storing Word and Excel documents in a document management system to manage your R&D process? If the answer to both of these questions is “Yes,” then Office is most likely your problem. Watch this webinar (https://www.youtube.com/watch?v=jaSouNZdtwc) and review the slides to learn why you should stop using Office to manage development assets, and how an artifact-centric tool can help you break the barriers to Agile adoption.
If you’re managing risk in Excel but your requirements are in a separate tool, you are creating a gap that has significant time costs to manage and increases the possibility of errors.
- How hard is it to keep your risk register updated as requirements change?
- Do you know the current status of your mitigating actions?
- Can you assign actions, see who is responsible for each action, and see if they are making progress?
- And, most importantly, can you relate all this information back to your requirements?
Review this webinar presentation to learn more about closing the gap between risk and requirements. Using an FMEA as an example, Gordon Alexander, Seapine Software solutions consultant, explains how an integrated risk and requirements management solution can save you time and help you systematically and continuously manage risks and requirements.
Many medical device development teams struggle with traceability, wasting hours, days, or even weeks creating and maintaining a traceability matrix. Other teams use integrated product development tools to more easily manage risk traceability and core artifacts.
Beyond FDA Compliance Webinar: 5 Hidden Benefits of Your Traceability MatrixSeapine Software
When created early in the product development lifecycle, a trace matrix can do more than just help you gain FDA approval for your device. Unfortunately, many companies create the matrix sporadically during a project, mainly right before regulatory submission—too late to capture the benefits a well-maintained matrix can deliver.
During this recorded webinar, guest speaker Steve Rakitin, President of Software Quality Consulting, discussed five of the benefits gained by maintaining a matrix throughout the project. A software engineer with more than 20 years of experience in the medical device industry, Steve explains how a trace matrix can help you:
- Plan and estimate testing and validation needs
- Ensure all requirements are implemented
- Verify that all requirements have been tested
- Manage change throughout product development
- Provide evidence that hazard mitigations are implemented and validated
In this presentation, which was recorded at the 2013 Medical Devices Summit West in San Francisco, David Vogel of Intertech Engineering and Aimee Raymond of Cordis discuss some current problems and solutions in medical device development, including how to:
- Manage the real hierarchy of harms, hazards, and causes
- Prioritize and manage risk
- Implement traceability to ensure risk controls have been implemented correctly
- Deal with overall risk assessment and residual risk
Use the Windshield, Not the Mirror Predictive Metrics that Drive Successful ...Seapine Software
Sharon Niemi, Practice Director of SQA, talks about how the right combination of predictive and reactive metrics can help you build a measurement portfolio that improves product quality and release consistency. You’ll learn how to build a measurement system that incorporates leading and lagging indicators to improve your team’s consistency in delivering quality products on time and within budget.
Leveraging Reusability and Traceability in Medical Device DevelopmentSeapine Software
Learn best practices for creating verifiable, traceable requirements. The presentation also includes information about how Seapine's TestTrack supports streamlining better processes, data capture, reusability, and traceability in the requirements phase and a Q&A session.
Neuro-symbolic is not enough, we need neuro-*semantic*Frank van Harmelen
Neuro-symbolic (NeSy) AI is on the rise. However, simply machine learning on just any symbolic structure is not sufficient to really harvest the gains of NeSy. These will only be gained when the symbolic structures have an actual semantics. I give an operational definition of semantics as “predictable inference”.
All of this illustrated with link prediction over knowledge graphs, but the argument is general.
Smart TV Buyer Insights Survey 2024 by 91mobiles.pdf91mobiles
91mobiles recently conducted a Smart TV Buyer Insights Survey in which we asked over 3,000 respondents about the TV they own, aspects they look at on a new TV, and their TV buying preferences.
UiPath Test Automation using UiPath Test Suite series, part 3DianaGray10
Welcome to UiPath Test Automation using UiPath Test Suite series part 3. In this session, we will cover desktop automation along with UI automation.
Topics covered:
UI automation Introduction,
UI automation Sample
Desktop automation flow
Pradeep Chinnala, Senior Consultant Automation Developer @WonderBotz and UiPath MVP
Deepak Rai, Automation Practice Lead, Boundaryless Group and UiPath MVP
LF Energy Webinar: Electrical Grid Modelling and Simulation Through PowSyBl -...DanBrown980551
Do you want to learn how to model and simulate an electrical network from scratch in under an hour?
Then welcome to this PowSyBl workshop, hosted by Rte, the French Transmission System Operator (TSO)!
During the webinar, you will discover the PowSyBl ecosystem as well as handle and study an electrical network through an interactive Python notebook.
PowSyBl is an open source project hosted by LF Energy, which offers a comprehensive set of features for electrical grid modelling and simulation. Among other advanced features, PowSyBl provides:
- A fully editable and extendable library for grid component modelling;
- Visualization tools to display your network;
- Grid simulation tools, such as power flows, security analyses (with or without remedial actions) and sensitivity analyses;
The framework is mostly written in Java, with a Python binding so that Python developers can access PowSyBl functionalities as well.
What you will learn during the webinar:
- For beginners: discover PowSyBl's functionalities through a quick general presentation and the notebook, without needing any expert coding skills;
- For advanced developers: master the skills to efficiently apply PowSyBl functionalities to your real-world scenarios.
UiPath Test Automation using UiPath Test Suite series, part 4DianaGray10
Welcome to UiPath Test Automation using UiPath Test Suite series part 4. In this session, we will cover Test Manager overview along with SAP heatmap.
The UiPath Test Manager overview with SAP heatmap webinar offers a concise yet comprehensive exploration of the role of a Test Manager within SAP environments, coupled with the utilization of heatmaps for effective testing strategies.
Participants will gain insights into the responsibilities, challenges, and best practices associated with test management in SAP projects. Additionally, the webinar delves into the significance of heatmaps as a visual aid for identifying testing priorities, areas of risk, and resource allocation within SAP landscapes. Through this session, attendees can expect to enhance their understanding of test management principles while learning practical approaches to optimize testing processes in SAP environments using heatmap visualization techniques
What will you get from this session?
1. Insights into SAP testing best practices
2. Heatmap utilization for testing
3. Optimization of testing processes
4. Demo
Topics covered:
Execution from the test manager
Orchestrator execution result
Defect reporting
SAP heatmap example with demo
Speaker:
Deepak Rai, Automation Practice Lead, Boundaryless Group and UiPath MVP
Transcript: Selling digital books in 2024: Insights from industry leaders - T...BookNet Canada
The publishing industry has been selling digital audiobooks and ebooks for over a decade and has found its groove. What’s changed? What has stayed the same? Where do we go from here? Join a group of leading sales peers from across the industry for a conversation about the lessons learned since the popularization of digital books, best practices, digital book supply chain management, and more.
Link to video recording: https://bnctechforum.ca/sessions/selling-digital-books-in-2024-insights-from-industry-leaders/
Presented by BookNet Canada on May 28, 2024, with support from the Department of Canadian Heritage.
Slack (or Teams) Automation for Bonterra Impact Management (fka Social Soluti...Jeffrey Haguewood
Sidekick Solutions uses Bonterra Impact Management (fka Social Solutions Apricot) and automation solutions to integrate data for business workflows.
We believe integration and automation are essential to user experience and the promise of efficient work through technology. Automation is the critical ingredient to realizing that full vision. We develop integration products and services for Bonterra Case Management software to support the deployment of automations for a variety of use cases.
This video focuses on the notifications, alerts, and approval requests using Slack for Bonterra Impact Management. The solutions covered in this webinar can also be deployed for Microsoft Teams.
Interested in deploying notification automations for Bonterra Impact Management? Contact us at sales@sidekicksolutionsllc.com to discuss next steps.
The Art of the Pitch: WordPress Relationships and SalesLaura Byrne
Clients don’t know what they don’t know. What web solutions are right for them? How does WordPress come into the picture? How do you make sure you understand scope and timeline? What do you do if sometime changes?
All these questions and more will be explored as we talk about matching clients’ needs with what your agency offers without pulling teeth or pulling your hair out. Practical tips, and strategies for successful relationship building that leads to closing the deal.
GDG Cloud Southlake #33: Boule & Rebala: Effective AppSec in SDLC using Deplo...James Anderson
Effective Application Security in Software Delivery lifecycle using Deployment Firewall and DBOM
The modern software delivery process (or the CI/CD process) includes many tools, distributed teams, open-source code, and cloud platforms. Constant focus on speed to release software to market, along with the traditional slow and manual security checks has caused gaps in continuous security as an important piece in the software supply chain. Today organizations feel more susceptible to external and internal cyber threats due to the vast attack surface in their applications supply chain and the lack of end-to-end governance and risk management.
The software team must secure its software delivery process to avoid vulnerability and security breaches. This needs to be achieved with existing tool chains and without extensive rework of the delivery processes. This talk will present strategies and techniques for providing visibility into the true risk of the existing vulnerabilities, preventing the introduction of security issues in the software, resolving vulnerabilities in production environments quickly, and capturing the deployment bill of materials (DBOM).
Speakers:
Bob Boule
Robert Boule is a technology enthusiast with PASSION for technology and making things work along with a knack for helping others understand how things work. He comes with around 20 years of solution engineering experience in application security, software continuous delivery, and SaaS platforms. He is known for his dynamic presentations in CI/CD and application security integrated in software delivery lifecycle.
Gopinath Rebala
Gopinath Rebala is the CTO of OpsMx, where he has overall responsibility for the machine learning and data processing architectures for Secure Software Delivery. Gopi also has a strong connection with our customers, leading design and architecture for strategic implementations. Gopi is a frequent speaker and well-known leader in continuous delivery and integrating security into software delivery.
Epistemic Interaction - tuning interfaces to provide information for AI supportAlan Dix
Paper presented at SYNERGY workshop at AVI 2024, Genoa, Italy. 3rd June 2024
https://alandix.com/academic/papers/synergy2024-epistemic/
As machine learning integrates deeper into human-computer interactions, the concept of epistemic interaction emerges, aiming to refine these interactions to enhance system adaptability. This approach encourages minor, intentional adjustments in user behaviour to enrich the data available for system learning. This paper introduces epistemic interaction within the context of human-system communication, illustrating how deliberate interaction design can improve system understanding and adaptation. Through concrete examples, we demonstrate the potential of epistemic interaction to significantly advance human-computer interaction by leveraging intuitive human communication strategies to inform system design and functionality, offering a novel pathway for enriching user-system engagements.
Elevating Tactical DDD Patterns Through Object CalisthenicsDorra BARTAGUIZ
After immersing yourself in the blue book and its red counterpart, attending DDD-focused conferences, and applying tactical patterns, you're left with a crucial question: How do I ensure my design is effective? Tactical patterns within Domain-Driven Design (DDD) serve as guiding principles for creating clear and manageable domain models. However, achieving success with these patterns requires additional guidance. Interestingly, we've observed that a set of constraints initially designed for training purposes remarkably aligns with effective pattern implementation, offering a more ‘mechanical’ approach. Let's explore together how Object Calisthenics can elevate the design of your tactical DDD patterns, offering concrete help for those venturing into DDD for the first time!
DevOps and Testing slides at DASA ConnectKari Kakkonen
My and Rik Marselis slides at 30.5.2024 DASA Connect conference. We discuss about what is testing, then what is agile testing and finally what is Testing in DevOps. Finally we had lovely workshop with the participants trying to find out different ways to think about quality and testing in different parts of the DevOps infinity loop.
Encryption in Microsoft 365 - ExpertsLive Netherlands 2024Albert Hoitingh
In this session I delve into the encryption technology used in Microsoft 365 and Microsoft Purview. Including the concepts of Customer Key and Double Key Encryption.