Michelle Kenny

Among other things, we are calling on Government to support industry-driven #dataspaces for #manufacturing using initiatives such as #Manufacturing-X and the #DigitalProductPassport4.0 (DPP4.0) which can be used to combine #compliance with #regulatory requirements and new data-driven #businessmodels.

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An excellent forum with abundant information to share! The world of Medical Devices is in a constant state of development and change

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Transversal skills: Skills that can be used in a wide variety of situations in life and in work. Leadership/Project Management/Problem Solving/Critical Thinking/Commercial Acumen/Communication/Strategic Thinking/Stakeholder Management On Thursday 27th June, I had the pleasure of attending the launch of "Talent to Thrive: The Future Skills Report for Irelands Medtech Sector", excellently compiled by Ann O'Connell & Team. The term "Transversal Skills" indeed resonated, and it was refreshing to see these mentioned as a fundamental requirement, as the MedTech Sector looks to continue its growth trajectory. I would contend that these "Transversal Skills" are a critical enabler not just limited to Medtech, but a necessity to be upskilled as Organizations continue to navigate this now normalized VUCA environment. (Volatile / Uncertain / Complex / Ambiguous) These skills, I believe, are of particular importance to the Supply Chain community, who have to understand the full End 2 End Value Chain, from Supplier (not just Tier 1 but multi-tiers) all the way to End Customer... Also, a special shout out to fellow Tipperary Man Liam Sheedy - who along with Caroline Currid, provided an insightful look into High Performance, touching on the Transversal Skillset, consistent standards, intelligent recovery and deep connection. An excellent launch of what promises to be a continued success story in Ireland's Medtech Journey... https://lnkd.in/dmuAPsN7

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Thrilled to see VCMG, with the support of DMI and Bosoton Scientific launching this new Community of Practice, driven by industry and supported by academia! We're living in an exciting era where disruptive technologies are rapidly transforming the manufacturing landscape. The ability for businesses to swiftly adapt to this evolving environment will be key to success. This initiative presents a unique opportunity for all of us to collaborate, share insights, and learn from one another, ensuring we can navigate these changes effectively and continue to grow together. #VCMG #AI #MachineVision

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​I’m excited to say Medtronic Ireland have signed a new agreement to get 50% of the energy for our Ireland sites from renewable sources. This power will now come from a windfarm just 30 minutes from our Parkmore site. It’s good to know we’re doing our bit as a company to protect the environment! #EngineeringTheExtraordinary #MedtronicProud #MedtronicEmployee https://bit.ly/3DgQV2l

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The MDSAP Program is continuing to grow as more countries are learning how they can leverage their resources to manage effective oversight of medical device manufacturers. Take a look at the information and let us know how we can help your organization.

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❕ Approx. 25% of quality defects in the industry can be attributed to human error. ❕ The Irish Medicines Board's analysis indicates that nearly 25% of quality issues, such as deviations, laboratory errors, complaints, and inspection concerns, are attributable to human error. To minimise these errors and ensure #product #safety, a comprehensive training approach is essential. In Germany, theoretical and practical training programmes equip professionals with the skills and knowledge needed to prevent errors. This dual focus helps maintain high standards in pharmaceutical manufacturing, improving both accuracy and safety. #PharmaQuality #TrainingExcellence #ProductSafety Source: https://lnkd.in/d2pdRKCS...

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In an increasingly digital era, we must explore how industry 4.0 technologies, such as #IOT, #Robotics, and #AI can improve efficiency and enhance productivity of #manufacturing - hear from the experts at this year's #MedtechRising24

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Quality audits are universally acknowledged as pivotal steps for regulatory adherence, serving as vital yet daunting tasks for all medical device manufacturers. There are a plethora of things a company must be ready with before undertaking a quality audit, these include but are not limited to: ✅ A management review meeting  ✅ An internal audit  ✅ A well-defined quality manual, policy, and objectives  ✅ A robust training system (https://lnkd.in/ddP6VWup) ✅ An effective document and record control system  ✅ Efficient supplier and purchasing controls ✅ A well-managed design and change control Given the extent of requirements, Audits and Inspections stands as a significant challenge for manufacturers; that is why I have crafted a checklist for Quality Audits that medical device companies can use. In this checklist, all the essential clauses and audit questions have been mentioned to ease the auditing process for your company. Here is the link to the template that you can download and start using to prepare for your next audit: ​​ https://lnkd.in/dFYS6sKr #medicaldevice #medicaldevicecompanies #medicaldevicemanufacturer #medicaldevices #medical #medicaldeviceaudit #qualityaudit #qms #qmsaudit #qmsauditchecklist #qualitymanagementsystem #medicaldeviceqms #medicaldeviceregulatory #medicaldeviceregulations #regulatoryrequirements #fda #fdarequirements #audits #qms #qmsauditing #internalaudits #externalaudits

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The FDA has released the Quality Management System Regulation (QMSR) Final Rule for the Current Good Manufacturing Practice (CGMP). What does this mean in practical terms? 💡 In summary, the FDA has aligned its Quality System (QA) Requirement with the international consensus standard ISO 13485. The new name for this regulation is the Quality Management System Regulation (QMSR). Now there remain only few discrepancies to the ISO 13485. The additional requirements mainly concern: - Complaint records, device labelling and packaging - Consistency with other FDA requirements - Some adjustments to terminology For further info, look under: https://lnkd.in/dqdqHzyK

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what a great summary of the NC vs. CAPA process. Well written.

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Why Being Human-Centric Attracts Top Talent In today’s world, the best talent looks for companies that get them as whole people. Medtronic is one of such companies. Here is example of Fiona, our colleague at Medtronic Galway: https://lnkd.in/eZdha6ah . Fiona can flex her hours around her training as an athlete—a setup that helps her thrive both at work and on the track. When companies are understanding and flexible, people feel supported and empowered. And that’s what really draws talent in: knowing they can succeed at work without giving up on their personal passions. Let’s build workplaces where people can be their full selves. #TalentAttraction #EmployeeExperience #medtronicemployee #FutureOfWork

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I’ll be speaking as part of Q1 Productions‘ “QMSR Implementation & Quality Management Enhancement Professional Education Course” 17-18 June 2024. The hosts are now offering a 50% discount with code QMSR50. With the FDA’s QMSR ruling of 02 Feb this year, greater emphasis has been placed upon the needs of Risk Management for Medical Devices. This being one of my favourite topics for the importance within Medical Device development, Risk Management (alongside the Design Controls process) are often being treated and regarded as, ”those painful document deliverables we need to have…” rather than the tools they can and should be to drive the development process. But when to start them? ISO 14971:2019 (and ISO 13485:2016) define the life cycle (that the standards are applicable to) as “..from the initial conception…”, yet the FDA’s QS Reg wording from 1996 defined in the preamble a period of research, “creativity and innovation” that the FDA would not expect design control requirements. With the QMSR, “…the FDA does not expect manufacturers to maintain records of all changes proposed during the very early stages of the design process…”. Although many manufacturers appreciate this caveat, I’ll be describing the risks (pun absolutely intended) of missing important design knowledge during those early design iterations and using the analogy of Agile Project Management processes to show. With an emphasis on Risk Management and the Design Control Processes as tools for development, rather than the perceived documentation need, I believe that focus on the activity and effort for the two will aid to deliver safe, effective and high-quality Medical Devices. I’ll walk through a detailed (and colourful!) flow-diagram for how this all comes together.

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🌟 Exciting News! 🌟 bioMérieux and #StJamesHospital in Dublin have recently launched the world’s first Data & IT Centre of Reference partnership! This groundbreaking collaboration aims to combat antimicrobial resistance (AMR) and improve sepsis management through innovative data and IT solutions. We’re incredibly proud to be part of this initiative that will enhance diagnostic accuracy and patient care. Together, we’re driving innovation in microbiology diagnostics! #HealthcareInnovation #PatientCare #SepsisAwareness #AntimicrobialResistance https://lnkd.in/eSizZfFN

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Quality is not only regulatory compliance.

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FDA's Obligation: To conduct inspections to confirm compliance 👮🏻🔎 Multiple comments to the FDA's QMSR centered around FDA accepting ISO audits and resulting certifications to ISO 13485 𝘪𝘯 𝘭𝘪𝘦𝘶 𝘰𝘧 FDA inspections 🙏🏻 One comment stated that FDA should allow firms with ISO certification to utilize that certification to demonstrate compliance with the QMSR, in furtherance of global harmonization. 🤝 FDA 𝗱𝗶𝘀𝗮𝗴𝗿𝗲𝗲𝘀 and clearly lays out its obligations which are: To inspect medical device manufacturers to 𝘤𝘰𝘯𝘧𝘪𝘳𝘮 𝘤𝘰𝘮𝘱𝘭𝘪𝘢𝘯𝘤𝘦 with the requirements of the FD&C Act and its implementing regulations...such as parts: ✅ 820 - Quality Management System Regulation ✅ 803 - Medical Device Reporting ✅ 806 - Corrections and Removals ✅ 821 - Medical Device Tracking ✅ 830 - Unique Device Identifier FDA believes that by incorporating the requirements of ISO 13485 within the QMSR, this will simplify manufacturers’ ability to comply with both ISO 13485 and requirements in the FD&C Act and its implementing regulations. So for the following groups of firms, this is either impactful or not: 1️⃣ US-domestic - QMSR + ISO 13485 (no ISO certification needed) 2️⃣ US-EU - QMSR + ISO 13485 + Certification to ISO 13485 3️⃣ EU-domestic - Certification to ISO 13485 (no QMSR compliance needed) 4️⃣ EU-US - Certification to ISO 13485 + QMSR Please share - what are your thoughts about FDA's decision NOT to accept ISO audits❓ ~~~ If you found this interesting or helpful, consider Reposting 🔄; follow me Vincent F. Cafiso and click the 🔔 so you don't miss future content.

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Great tips here…. As we know, beginning with the end in mind - one of the seven habits of highly effective people espoused by Stephen M. R. Covey - is so critical in any project, but even more so with life impacting #medicaldevices. Part of that end objective involves keeping sight of compliance activities throughout the whole design and development process ensuring achievememt of your end goal. Check out the blog to find out more.

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Medtronic Ireland will now get 50% of the power for our Irish sites from a wind farm 30 minutes from our Parkmore location. I’m so proud that we’re reducing our carbon footprint as a company and doing the right thing to protect the planet #EngineeringTheExtraordinary #MedtronicProud #MedtronicEmployee https://bit.ly/49S90jh

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