About
Accomplished Senior Leader in Software Engineering known for successfully establishing…
Experience
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Education
Licenses & Certifications
Publications
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Medical Device Software Traceability
Springer Verlag Publishers
F. McCaffery, Valentine Casey, M S Sivakumar, Gerry Coleman, Peter Donnelly, John Burton, “Medical Device Software Traceability”, Software and Systems Traceability, Ed. Andrea Zisman, Jane Cleland-Huang and Olly Gotel, Springer Verlag Publishers, Jan 2012, ISBN 978-1-4471-2238-8
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Risk management capability model for the development of medical device software
Springer
Software Quality Journal
Volume 18, Number 1, 81-107, DOI: 10.1007/s11219-009-9086-7Other authors -
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The Medical Device Industry: Developments in Software Risk Management
Cambridge Scholars Publishing
See publicationThe Medical Device industry is one of the fastest growing industries in the world. Device manufacturers are producing increasingly sophisticated and complex medical device software to differentiate themselves in the battle for dominance in this sector. The increase in the complexity of medical device software has introduced new challenges with respect to making medical devices and their associated software safe. Risk management has emerged as key in addressing these challenges. Existing…
The Medical Device industry is one of the fastest growing industries in the world. Device manufacturers are producing increasingly sophisticated and complex medical device software to differentiate themselves in the battle for dominance in this sector. The increase in the complexity of medical device software has introduced new challenges with respect to making medical devices and their associated software safe. Risk management has emerged as key in addressing these challenges. Existing literature on risk management for medical devices has been slow to adequately account for the complex nature of software in modern medical devices. Conversely, excellent progress has been made in the broader Software Engineering community with the production of holistic software risk based models such as the Capability Maturity Model Integration (CMMI[registered]) and SPICE[trademark]. However, these models do not account for medical device specific requirements. This book examines the possibility of a unified approach whilst investigating the relevance of the CMMI[registered] SPI model to the medical device regulatory requirements.
Honors & Awards
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Excellence in IT Award
General Motors IT
Awarded to one person in General Motors Global IT Organization each quarter ‘in recognition of efforts to go above and beyond the call of duty to delight business partners, deliver exceptional business results and provide breakthrough innovation’.
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Nvolve
*Press Release*-Everfield, a long-term investor and growth accelerator for European B2B software companies, has partnered with Nvolve, a leading Irish provider of cloud-based employee enablement, skills, and training software, designed specifically for frontline workers. Nvolve’s platform enables frontline workers, typically warehouse and food production site staff, to record and digitally sign off training and compliance with standard operating procedures (SOPs) from the shop floor. This ensures compliance with audit requirements, customer contracts, and regulations. The partnership enables Nvolve to scale its team to continue to support its growing customer base across food & beverage, logistics, healthcare and manufacturing. "We are delighted to be partnering with Everfield," said Barry Harper, CEO at Nvolve. "Everfield's expertise in growing European software business is invaluable as we continue to enhance our products and services for our existing customers and reach new ones. We are confident that this partnership will help us to achieve our long-term goals." To read the release in full see here. https://hubs.ly/Q02WN6g00 #nvolve #frontlineworkers #investment #partnerships #employeeenablement #workplacetraining #SOP #compliance
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Damian Erangey
📣 Attention Cork businesses! Discover how AI can transform your operations at our upcoming event. Join Neil Bowden to gain practical insights into leveraging AI for productivity, innovation, and staying competitive, learn about the latest advancements from Dell Technologies, and discover how to effectively integrate AI into your business strategy. Don’t miss out! #DellTechnologies #AI #BusinessGrowth #CorkEvents
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Processus BPM Limited
It's time for a 99 and some reflection! Summer is here and the temperature is rising. This is an opportunity to improve business processes. Most decisions to change software are down to poor implementation and being sold a solution that is not what the business needs. For many successful Irish businesses, the software decisions are right the business is continuing to evolve and the business processes need to be agile like the business. Sometimes an external set of eyes can throw light on issues that seem bigger than they are. An independent software consultant with over 25 years of experience could shine a light on these issues and give simple fixes for them or help you navigate your way to a software solution that is fit for purpose. Reach out for a chat about what options are available to your business, it's good to talk!
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Christopher Heaney
🚀 4 Days to Go! 🚀 To mark the final stretch to the Limerick Chamber Regional Business Awards, here are our 4 essential tips for creating and maintaining a successful website—just a few of the insights that keep WebDevBuilders Ltd on track to deliver excellence for our clients: 1. Buy your domain name yourself Owning your domain is key to keeping control over your online identity! We recommend reliable providers like HostingIreland.ie for a smooth process. 2. Keep your website and domain name hosting separate Separating these gives you more flexibility and control if you need to change providers or troubleshoot. It can also boost security and reduce downtime. 3. Always have a website backup available A backup is your safety net. Websites can face issues from updates or attacks, so having a recent backup can save you time and headaches in a crisis. 4. Prioritize mobile responsiveness With over half of web traffic coming from mobile devices, ensuring your website looks and performs well on mobile is essential. This improves user experience, search engine rankings, and accessibility. These are just a few ways we help clients build strong, resilient websites. Stay tuned as we count down to the big day - 4 days to go! #WebDevelopment #DigitalSuccess #WebsiteTips #WebsiteDesign #SmallBusinessTips
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Ciara Greaney
Decisions, Decisions.... The last webinar in the spring series is just a few days away. If you haven't already signed up, there is still time! you can do so at www.whitespire.ie I have covered this topic in workshops a number of times before and the takeaway that emerges is that decision making bottlenecks are heightened if trust is low or company objectives are ambiguous. In this webinar I'll talk about how to put in guiderails to allow people to make decisions with confidence within their sphere of control. Check it out on Monday! #decisionmaking #leadership #operationalexcellence
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QA Financial
INTERVIEW - Test Triangle CEO Praveen Madire on navigating the crowded, competitive QA space "Test automation poses ongoing challenges, encompassing the identification of suitable test cases, script maintenance, and adaptation to evolving technologies," Dublin-based Madire told QA Financial in an exclusive interview. Read the whole conversation here -> https://lnkd.in/dWA38Be8 #DevOps #RPA #MobileTesting #QA #SoftwareTesting #Automation #LLM #ITsecurity #AI #QATesting
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Scaled Agile, Inc.
Another Tuesday, another powerful soundbite from a leader in the Agile community. For today's Tactical Tip podcast, SPCT candidate and former RTE Diego Groiso with Cprime | Elabor8 joins us to share two amazing tips for how Release Train Engineers (RTEs) can keep on top of commitments and work smarter this year. #ScaledAgileFramework #ScaledAgile #Podcast #RTE #Agile
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Enterprise Ireland MENA
Enterprise Ireland is proud to support a number of innovative #Irish HRTech companies at Expand North Star. The #HRTech sector in the #GCC region is undergoing a significant transformation, presenting a wealth of opportunities for #innovative Irish companies. Key trends and opportunities in this sector include innovative solutions pertaining to #digital transformation, #AI and #automation, remote work solutions, employee experience & wellbeing, among others. GITEX GLOBAL Largest Tech & Startup Show in the World is the perfect platform for companies looking to make headway in this dynamic market. The region's leading tech event provides exceptional networking opportunities, cutting-edge trend insights, and a platform to highlight #innovative solutions. Join us at Expand North Star to explore the latest trends and opportunities emerging across the region. Contact Enterprise Ireland MENA's HRTech Specialist, Cara Edwards, to learn more about how your company can tap into this thriving market. #gitexglobal #gitex #expandnorthstar #mena #internationaltrade #export #businessopportunities #marketopportunities #technology #hr #tech
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Ronan J. McCabe
Ireland's National Treatment Purchase Fund (NTPF) is tasked with managing healthcare wait times and enhancing patient access to treatment. Faced with a challenge of consolidating vast, fragmented healthcare data, the NTPF needed a more effective way to provide visibility into patient queues, facilitate better decision-making, and improve accountability across the healthcare sector. To address these issues, NTPF partnered with Spanish Point Technologies and Microsoft to develop the Patient Access Management System (PAMS) using Power Platform. Since the launch in 2019, the number of patients managed through PAMS has grown from 30,000 to over 160,000 - with a significant reduction in patient waiting times. Looking forward, NTPF aims to expand this data solution across more healthcare facilities in Ireland, further strengthening the country's healthcare infrastructure. For more details on this impactful digital transformation, explore the full story on how the NTPF is shaping a more efficient healthcare future. Read more: https://lnkd.in/eaiMi93K #msftadvocate #Ireland #healthcare #powerBI #data
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EY
🏥 At St James's Hospital Dublin , digital innovation, Microsoft cloud technology, and AI are transforming patient care. 🤝 EY Ireland is proud to have partnered with St. James's Laboratory team to achieve faster diagnoses, improve service user and workforce experience, and enhance overall patient care. ⏱️ Fiona Kearney and her team have been able to reduce National MRSA Reference laboratory processing times from nine hours to less than two hours and enhance their data capabilities with advanced analytics and unlimited cloud storage. 🚀 Additionally, the team at St. James's Hospital Laboratory has improved efficiency through better compliance and comprehensive user training. 📲 AI is creating new value for organisations across all industries and this how we shape the future – https://go.ey.com/3ZgxLAV 🎥 Watch this video to see how St. James's Hospital have elevated patient care. #FutureWontWait #ShapeTheFutureWithConfidence Paul Browne | Brian Moroney | John Ward | Tim Bergin | Eoin O'Reilly | Carol Murphy | Ronan Glynn | Caitríona Malone
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Digital Transformation Flexible Fund
Why Choose DTFF to Drive Digital Transformation? The Digital Transformation Flexible Fund (DTFF) isn’t just a funding scheme – it’s a game-changer for small and micro businesses and social enterprises across Northern Ireland. By supporting up to 70% of eligible costs, DTFF makes advanced digital technologies like IoT, AI, robotics, and blockchain more accessible. What does this mean for your business? Lower financial risk and a higher potential for growth, innovation, and efficiency. Whether you’re looking to streamline operations or expand into new markets, DTFF can help you achieve your goals. Don’t miss out on this opportunity to lead in your industry. Explore funding opportunities: https://lnkd.in/d4HarYAz #DTFF #Innovation #DigitalTransformation #NIbusiness #Funding
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Causeway Coast and Glens Borough Council
The Digital Transformation Flexible Fund (DTFF) isn’t just a funding scheme – it’s a game-changer for small and micro businesses and social enterprises across Northern Ireland. By supporting up to 70% of eligible costs, DTFF makes advanced digital technologies like IoT, AI, robotics, and blockchain more accessible. What does this mean for your business? Lower financial risk and a higher potential for growth, innovation, and efficiency. Whether you’re looking to streamline operations or expand into new markets, DTFF can help you achieve your goals. Don’t miss out on this opportunity to lead in your industry.
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Business Post
B2B office supplier Codex Office Solutions has appointed Audrey Jenkins as its new head of customer experience. Jenkins previously managed the customer service department at Codex for more than five years, having joined the company initially as a temp to support a system migration. Prior to Codex, she held roles at Eir and her leadership experience spans more than a decade, during which time she spearheaded numerous initiatives aimed at enhancing operational efficiencies and customer relations. Read more here - https://lnkd.in/eKD8JZax
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