What do hospital beds, blood pressure cuffs, dosimeters, and pacemakers all have in common? They are all medical devices with software that regulates their functionality in a way that contributes to Basic Safety or Essential Performance. With the FDA reporting that the rate of medical device recalls between 2002 and 2012 increased by 100% – where software design failures are the most common reason for the recalls – it’s no wonder IEC 62304 has been implemented. Its implementation, however, has medical device manufacturers asking questions about if, when and under what circumstances the standard is required.
This article explains what IEC 62304 is, when medical devices must comply with it and how IEC 62304 compliance is assessed.
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
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
Applying IEC 62304 Risk Management in Aligned Elements - the medical device ALMAligned AG
A concrete example of linking risk management using a preliminary hazard analysis approach with the software architecture when applying IEC 62304 in a medical device ALM.
How to Achieve Gapless End-to-End Traceability in Hardware and Software Devel...Intland Software GmbH
Maintaining traceability throughout the lifecycle helps a great deal in staying in control of your development processes, whether it’s a hardware or software product that you are working on. It could help improve processes, product quality, transparency, and cost control. Watch this webinar recording to learn how codeBeamer can help you ensure traceability between all your work items across the entire lifecycle, even across projects.
What do hospital beds, blood pressure cuffs, dosimeters, and pacemakers all have in common? They are all medical devices with software that regulates their functionality in a way that contributes to Basic Safety or Essential Performance. With the FDA reporting that the rate of medical device recalls between 2002 and 2012 increased by 100% – where software design failures are the most common reason for the recalls – it’s no wonder IEC 62304 has been implemented. Its implementation, however, has medical device manufacturers asking questions about if, when and under what circumstances the standard is required.
This article explains what IEC 62304 is, when medical devices must comply with it and how IEC 62304 compliance is assessed.
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
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
Applying IEC 62304 Risk Management in Aligned Elements - the medical device ALMAligned AG
A concrete example of linking risk management using a preliminary hazard analysis approach with the software architecture when applying IEC 62304 in a medical device ALM.
How to Achieve Gapless End-to-End Traceability in Hardware and Software Devel...Intland Software GmbH
Maintaining traceability throughout the lifecycle helps a great deal in staying in control of your development processes, whether it’s a hardware or software product that you are working on. It could help improve processes, product quality, transparency, and cost control. Watch this webinar recording to learn how codeBeamer can help you ensure traceability between all your work items across the entire lifecycle, even across projects.
Check out our last webinar to learn more about managing the parallel and interconnected lifecycles of hardware, software and service development involved in the creation of IoT-enabled products. During a live demonstration, this webinar will give you a chance to learn how codeBeamer ALM helps you connect and manage these lifecycles (xLM) simultaneously to maximize efficiency.
ISO 62304: Defines processes that are required in any given SDLC to ensure that it compiles with the creation or maintenance medical device software
Andy Stopford has over 16 years experience leading teams to deliver pioneering software solutions that enable business goals to be achieved. With experience drawn from the e-commerce, financial, insurance, banking and healthcare sectors he is committed to creating quality software that adheres to best practices and delivers solutions that are robust and help clients achieve business goals.
Andy is a software engineer by trade and is a published book author and keen writer with 200 magazine and journal articles over his career. He has a great depth and breadth of knowledge in a variety of technologies and is passionate about all things software engineering.
Andy leads the HAVAS HEALTH SOFTWARE team of software engineers to develop solutions that focus on the best possible outcome for the end user that ensure the business needs are met.
@andystopford
Software occupy an increasingly prominent place in the critical embedded systems : their size and complexity is increasing , while their criticality also continues to rise. In this context, how the aeronautical, space , automotive, industrial domains are facing these challenges ? Application of international standards is essential to define the scope of practices recognized by the community as " state of the art " in terms of producing safety critical software . What are these practices, the principles on which they are built ? Starting with (re)defining the concept of software criticality and placing this concept in the whole system, then we will try to answer all these questions. During this presentation , we will illustrate the point with examples from aeronautics, air traffic control , space , automotive or railway . Finally, we will take a look at some trends , particularly through standards recently released.
Presentation on the promises and pitfalls of applying Agile in a Quality Management System. How do you get the benefits of agile while maintaining quality and regulatory compliance?
Compliance with medical standards iec 62304, iso 14971, iec 60601, fda title ...Intland Software GmbH
Check out our latest webinar to learn more about complying with IEC 62304, ISO 14971, IEC 60601, and relevant FDA regulations (for instance, Title 21 CFR Part 11 about electronic signatures). In this webinar, we discussed the requirements set forth by these standards. We also showed our Intland's Medical IEC 62304 Template to leverage codeBeamer ALM's advanced capabilities and to facilitate compliance with these regulations.
The medical device industry is facing unprecedented challenges due to emerging technologies and increased regulatory scrutiny.
Current “waterfall” product development methods are ill-suited to dealing with the pace of change and uncertainty that product development organizations are facing. This eBook addresses:
* The shortcomings of waterfall development specifically in regulatory environments.
* How agile development meets the safety, reliability and regulatory needs of the medical device and diagnostics industry.
* How agile development can help ensure delivery of successful software.
Presentation by Pathfinder Software to the Agile Project Management Group and Health 2.0 group on how to get the benefits of agile development in an FDA regulated environment, based on Pathfinder's experience developing software for medical devices
Death by documentation - Medical Device Development ChallengesAligned AG
“Writing documents and putting them into binders does not sound like rocket science.”
Nevertheless, many of us have experienced how documentation and traceability according to ISO 13485 and FDA QSR 820 turns into a both complex and cumbersome activity. Surprisingly enough, as long as regulatory demands are met, the documentation process itself is seldom scrutinized for efficiency improvements.
This presentation highlights how great savings can be made in this area. We uncover bad documentation practices, their consequences and potential remedies with the intent to make the medical device documentation process more efficient.
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.
The presentation describes how to conduct reliability planning and testing for software controlled electron-mechanical systems. It is based on working experience in US FDA, FCC and European CE regulated companies. The presentation provides practical and rational steps to improve product reliability and comply with applicable regulations.
研讨会简报介绍了如何进行软件控制的电子机械系统的可靠性规划和测试。它是基于在美国FDA,FCC和欧洲CE规管公司的工作经验。研讨会演示文稿提供仅结合实际,合理的措施来提高产品的可靠性,并遵守适用的法规.
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.
Biomedical engineering work is subjected to stringent regulatory constraints that mandate a robust engineering process that conforms to all pertinent regulatory guidelines and imperatives.
Software development is an important component of any engineering project and as such, it should be equally addressed and properly integrated with the overall engineering process. To that effect, the following software development process is proposed. This process attempts to be well grounded in the nature of innovative Biomedical engineering work. There are inherent significant technology risks related to the development of innovative biomedical devices. These risks must be correctly identified, and mitigated throughout the entire engineering process. The main benefit of the software development process presented here is its explicit management of software risk factors as recommended by modern successful software development practices.
Dr. Andreas Birk: Approaches to Agile in Medical Device DevelopmentIntland Software GmbH
This slide deck accompanied Dr. Andreas Birk's webinar on 4 Mar 2021 on the use of Agile in the development of medical technology. Flick through the presentation, or watch a recording of this webinar on Intland Software's website: https://intland.com/webinar-recording/approaches-to-agile-in-medical-device-development-webinar-recording/
Download the accompanying white paper: https://content.intland.com/approaching-agile-in-medical-device-development
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.
Many organisations operatin in highly regulated environments, such as healthcare, have concluded that in order to achieve the next level of product quality and safety improvements, not to mention enhanced competitiveness, adoption of a more Agile approach is required. In this presentation, you will learn how the Agile software development approach for high assurance systems addresses many of the challenges found in many highly regulated enterprise environments.
Presented by Craig Langenfeld
Check out our last webinar to learn more about managing the parallel and interconnected lifecycles of hardware, software and service development involved in the creation of IoT-enabled products. During a live demonstration, this webinar will give you a chance to learn how codeBeamer ALM helps you connect and manage these lifecycles (xLM) simultaneously to maximize efficiency.
ISO 62304: Defines processes that are required in any given SDLC to ensure that it compiles with the creation or maintenance medical device software
Andy Stopford has over 16 years experience leading teams to deliver pioneering software solutions that enable business goals to be achieved. With experience drawn from the e-commerce, financial, insurance, banking and healthcare sectors he is committed to creating quality software that adheres to best practices and delivers solutions that are robust and help clients achieve business goals.
Andy is a software engineer by trade and is a published book author and keen writer with 200 magazine and journal articles over his career. He has a great depth and breadth of knowledge in a variety of technologies and is passionate about all things software engineering.
Andy leads the HAVAS HEALTH SOFTWARE team of software engineers to develop solutions that focus on the best possible outcome for the end user that ensure the business needs are met.
@andystopford
Software occupy an increasingly prominent place in the critical embedded systems : their size and complexity is increasing , while their criticality also continues to rise. In this context, how the aeronautical, space , automotive, industrial domains are facing these challenges ? Application of international standards is essential to define the scope of practices recognized by the community as " state of the art " in terms of producing safety critical software . What are these practices, the principles on which they are built ? Starting with (re)defining the concept of software criticality and placing this concept in the whole system, then we will try to answer all these questions. During this presentation , we will illustrate the point with examples from aeronautics, air traffic control , space , automotive or railway . Finally, we will take a look at some trends , particularly through standards recently released.
Presentation on the promises and pitfalls of applying Agile in a Quality Management System. How do you get the benefits of agile while maintaining quality and regulatory compliance?
Compliance with medical standards iec 62304, iso 14971, iec 60601, fda title ...Intland Software GmbH
Check out our latest webinar to learn more about complying with IEC 62304, ISO 14971, IEC 60601, and relevant FDA regulations (for instance, Title 21 CFR Part 11 about electronic signatures). In this webinar, we discussed the requirements set forth by these standards. We also showed our Intland's Medical IEC 62304 Template to leverage codeBeamer ALM's advanced capabilities and to facilitate compliance with these regulations.
The medical device industry is facing unprecedented challenges due to emerging technologies and increased regulatory scrutiny.
Current “waterfall” product development methods are ill-suited to dealing with the pace of change and uncertainty that product development organizations are facing. This eBook addresses:
* The shortcomings of waterfall development specifically in regulatory environments.
* How agile development meets the safety, reliability and regulatory needs of the medical device and diagnostics industry.
* How agile development can help ensure delivery of successful software.
Presentation by Pathfinder Software to the Agile Project Management Group and Health 2.0 group on how to get the benefits of agile development in an FDA regulated environment, based on Pathfinder's experience developing software for medical devices
Death by documentation - Medical Device Development ChallengesAligned AG
“Writing documents and putting them into binders does not sound like rocket science.”
Nevertheless, many of us have experienced how documentation and traceability according to ISO 13485 and FDA QSR 820 turns into a both complex and cumbersome activity. Surprisingly enough, as long as regulatory demands are met, the documentation process itself is seldom scrutinized for efficiency improvements.
This presentation highlights how great savings can be made in this area. We uncover bad documentation practices, their consequences and potential remedies with the intent to make the medical device documentation process more efficient.
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.
The presentation describes how to conduct reliability planning and testing for software controlled electron-mechanical systems. It is based on working experience in US FDA, FCC and European CE regulated companies. The presentation provides practical and rational steps to improve product reliability and comply with applicable regulations.
研讨会简报介绍了如何进行软件控制的电子机械系统的可靠性规划和测试。它是基于在美国FDA,FCC和欧洲CE规管公司的工作经验。研讨会演示文稿提供仅结合实际,合理的措施来提高产品的可靠性,并遵守适用的法规.
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.
Biomedical engineering work is subjected to stringent regulatory constraints that mandate a robust engineering process that conforms to all pertinent regulatory guidelines and imperatives.
Software development is an important component of any engineering project and as such, it should be equally addressed and properly integrated with the overall engineering process. To that effect, the following software development process is proposed. This process attempts to be well grounded in the nature of innovative Biomedical engineering work. There are inherent significant technology risks related to the development of innovative biomedical devices. These risks must be correctly identified, and mitigated throughout the entire engineering process. The main benefit of the software development process presented here is its explicit management of software risk factors as recommended by modern successful software development practices.
Dr. Andreas Birk: Approaches to Agile in Medical Device DevelopmentIntland Software GmbH
This slide deck accompanied Dr. Andreas Birk's webinar on 4 Mar 2021 on the use of Agile in the development of medical technology. Flick through the presentation, or watch a recording of this webinar on Intland Software's website: https://intland.com/webinar-recording/approaches-to-agile-in-medical-device-development-webinar-recording/
Download the accompanying white paper: https://content.intland.com/approaching-agile-in-medical-device-development
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.
Many organisations operatin in highly regulated environments, such as healthcare, have concluded that in order to achieve the next level of product quality and safety improvements, not to mention enhanced competitiveness, adoption of a more Agile approach is required. In this presentation, you will learn how the Agile software development approach for high assurance systems addresses many of the challenges found in many highly regulated enterprise environments.
Presented by Craig Langenfeld
This presentation is intended for the customer facing risk managers, sales staff, and IT staff of a medical device manufacturer and their medical doctors and IT hospital and clinical counterparts.
It is intended to give an overview and highlight process considerations for incident management and reporting of cybersecurity issues.
It is based on the technical paper published by Pam Gilmore and Valdez Ladd in the ISSA Journal in 2014.
The software development life cycle (SDLC) is a framework defining tasks performed at each step in the software development process. SDLC is a structure followed by a development team within the software organization. It consists of a detailed plan describing how to develop, maintain and replace specific software.
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.
Bringing User-CenteredDesign Practices intoAgile Development Projectsabcd82
Bringing User-CenteredDesign Practices intoAgile Development Projects -This full day tutorial seeks to explain Agile Development\'s incremental release and iterative development strategy from the perspective of a user centered design practitioner. Practical advice is given on making Agile development more user-centric.
Getting Executive Support for a Software Security ProgramCigital
Software security is one of many competing priorities within your organization. How do you get the attention and budget you need? This presentation walks you through ways to build executive support
Learn how to establish a greater sense of confidence in your release cycle, along with the practices and processes to create a high-performing engineering culture within your team.
CRJS466 – Psychopathology and CriminalityUnit 5 Individual Proje.docxfaithxdunce63732
CRJS466 – Psychopathology and Criminality
Unit 5 Individual Project Grading Criteria
(125 points)
Content (75 points):
Question 1 (20 points)
Question 2 (20 points)
Question 3 (15 points)
Question 4 (20 points)
Organization (25 points):
Clarity and conciseness of thought, minimum page length
APA Formatting (12.5 points):
Title page with Running head, page numbers, 12-pt. Times New Roman or
Arial font, 1” margins, spacing, in-text citations, and References (minimum of
three peer-reviewed, scholarly sources)
Mechanics (12.5 points):
Grammar, spelling/word usage, punctuation
______________________________________________________________________
For the Unit 5 IP, below are the specific questions and my expectations:
In a 3–5 page position paper, respond to the following:
(1) Articulate the mental disorder being considered by the court in the case that you selected, and why this disorder would make the defendant unfit for trial.
**Based on information and knowledge gathered from the DSM-IV-TR or DSM-5, course text, Live Chats, Learning Materials, and other peer-reviewed/scholarly sources, determine ONE possible mental disorder being considered. Discuss your rationale as to why you selected the diagnosis for this particular case. Before choosing a disorder, think about the defendant's mental status, including appearance, attitude, behavior, mood and affect, speech, thought process, thought content, perception, cognition, insight, and judgment.
(2) Explain the relationship between the actions and behavior that would cause the court to remand the defendant for a mental evaluation.
**Address the association between the actions or offenses of the defendant and the mental disorder associated with the offense.
(3) Evaluate the outcome of the case you selected in terms of the defendant, the victim, and the community.
**Identify the impact of the trial’s outcome on the community, the victim, and the defendant.
(4) Critique and assess the court’s decision in the case you selected. Choose ONE of the following:
(a) Support the court’s correct decision.
**Discuss why you support (agree with) the court's decision. Explain your rationale.
(b) Challenge the court’s decision with your supported reasons.
**Discuss why you challenge (disagree with) the court's decision. Explain your rationale.
SWE440-1402A-01
Software Project Management
Project Plan
27 April 2014
Content
Page
1)Project Description and Methodology
3-6
2)Project Plan Outline
7-8
3)ISO & IEEE Standard
9-11
4)Configuration Management
12-16
5)Defect Tracking
17
6)Risk Management
19-22
7) Final Project Report
23
8)References
24
Project Description and Methodology
The IT ecosystem of financial services institutions faces many challenges in aligning business needs with IT solutions which generally.
Software organizations that want to maximize the yield of Software Testing find that choosing the right testing strategy is hard, and most testing managers are ill-prepared for this. The organization has to learn how to plan testing efforts based on the characteristics of each project and the many ways the software product is to be used. This tutorial is intended for Software professionals who are likely to be responsible for defining the strategy and planning of the testing effort and managing it through its life cycle. These roles are usually Testing Managers or Project Managers.
4 Quality System Musts for Medtech Startups to Get Safer Products to Market F...Greenlight Guru
Medical device startups have a pile of things to address yet often don’t have the pile of money to take care of everything that is needed. Because of this, a medical device quality system often gets pushed to the back burner in favor of activities that are perceived to add more value and meaning to the startup.
Ignoring a quality system entirely until after development is complete and the product is launched is not a good idea.
A medical device startup should treat the development of a quality management system in a similar fashion as the development of a medical device. Learn how to build your medical device quality system as you go.
DevSecOps is a new way to deliver security as part of the Software Supply Chain. It supports a built-in process and faster security feedback loop for DevOps teams.
Understanding the who, what, why, and when of quality is essential in implementing an effective Quality Program. It requires a combination of distinct disciplines: Quality Assurance, Quality Control, and Quality Improvement. They are three unique disciplines which, when used together, can improve the efficiency and effectiveness of any organization leading to reduced cost and increased customer satisfaction.
Transitions to Agile software development always seems complicated when it comes to QA. There are a lot of DOs and DON'Ts but it always seems that 2-3 weeks is not enough for all. In this presentation I cover how a change your mindset and on how you look at the typical problems you can address your challenges with ease and create a mindful process for your organization
Embarking on a software development journey for startups can be a thrilling yet daunting experience. It's a path filled with twists and turns, and challenges that can make or break your success. But fear not, for there are solutions and proven strategies that can help you achieve your goal of successful product development. Join us on this exciting adventure as we explore the secrets to unlocking your startup's full potentia
2. Short presentation of me
Robert Ginsberg
• 26 years in SW
• 17 years in Medical Device SW
• Participated in approx 20 audits,
FDA, MDD, etc.
• Co-author of IEC/ISO 62304
• Lean believer . Implemented agile
software methods at two large medical
companies
3. Short survey
Who has worked hands on with agile
methods for software?
Enter
Yes No
5. Time line
2005
Rup, XP FDD
Lean Manufacturing
Lean Development
Lean Manufacturing
Aha …. (Mary Poppendieck, Lean Development)
2003 2004 2005 2006 2007 2008
2002 2009
6. Why Lean – challenges to conquer?
To meet challenges such as:
• Ever increasing innovation pace
• Managing increasing complexity
• Being an attractive employer
7. Innovation, are we taking care of the knowledge?
Explicit knowledge
Conscious tacit
knowledge
Unconcious tacit
knowledge
individual
team
Higher value
Source: Bartholomew, David. Sharing Knowledge. David
Bartholomew Associates, 2005
8. ”The thorniest problem we have with software is its
complexity” Mays, IBM 1994
Chaos
Com-plexity
Ambiguity
Simplicity Com-plexity
People
Technology
Require-ments
10. Why Lean – gains
• Higher quality and productivity
• Better usage of the total knowledge in your
organization
• Higher level of innovation
• Higher focus on value added activities
• Feedback loops and focus on impediments
11. The Lean tool box for Sw
Scrum
TDD (&
refacto-ring)
Integration
Centric
Development
Continuous
integration
Visuali-sation
18. Integration Centric Development
Focus on early integration to:
• Mitigate risks
• Keep focus on the
product
• Get early customer
feedback
19. Going agile, impediments
• Affects many key roles in the company and may
cause uncertainty and ”turf war”
• There is usually an outer framework, that the agile
approach has to comply with
• Difficult to establish the product owner role
• Hard to get requirements, developers and testers to
go in the same pace
• Sets high expectations on people
20. Authorities, what do they say?
• Wants evidence that we:
– Have done our best to make a safe
product, ”Risk management”
– That we are In-the-state-of-control
• Manufacturer decides on processes
and tools used
• Must be easy and efficient to audit
21. Can standards help?
• FDA has been deeply involved
in development of both 14971
and 62304
• Those will affect and in the long
run replace several of the
current guidelines from FDA
No standard can override QSR!
22. 62304 in relation to other standards
ISO/IEC 60601-1-6
(Usability)
ISO/IEC 60601-1 issue 3
(Safety & ess performance)
ISO 14971
(Risk Management)
ISO/IEC 62304
(SW Process Management)
23. 62304 content
• Based on 60601-1-4 and AAMI 68
• Defines minimal levels for process activities
• Aligned with FDA´s expectations and terminology
• Takes different approach than 61508 –
manufacturer best suited to choose best
processes, techniques and tools
Biggest home work for many companies:
Integrated SW risk management
24. Integrated risk management
• Focus of effort and money
• Traceability risk measures – reqs – verification is a
key issue
• Enables efficient documentation
• Tool support is critical when combined with agile
approach, e.g. configuration management
• Several agile techniques are recognized and
encouraged by FDA, e.g. Test Driven Development,
Design-by-contract, Misra, etc
25. Agile - hands on, where to start?
• Cross functional teams
• Visualization, sprints, backlog
• Pair programming
• Test Driven Development
• Continuous Integration
• Integration Centric Development
26. Going agile, recommendations
• Start in small scale -> evaluate -> adapt
• Create a good mix of Top down and
Bottom up implementation
• Visualize impediments and progress !!!
• Invest in training
• Communicate, communicate,
communicate …
27. Summary
Agile sw
develop-ment
62304
Efficient
and
compliant
Sw process
28. Qadvis contact details
Qadvis is a consultant company for Quality and
Global Regulatory for Medical Devices.
Contact:
www.qadvis.com
info@qadvis.com
Tel +46 8 601 01 05