Element RegNav’s Post

The concept for Element RegNav was in part, borne out of the experiences that James Pink, Nicole Small and I had during the COVID-19 pandemic supporting the development and scale-up of critical healthcare products including ventilators. We experienced first hand, the challenges that innovators and established manufacturers faced in identifying requirements and establishing the safety & performance of products. Fundamentally, we want to help enable medical device manufacturers to enhance, extend and improve the lives of people. We can help ensure that you've critically considered safety & performance and in doing so, streamline your development process, reduce your time to market, minimize costs and accelerate access to your innovative products for patients, users and the public. #medicaldevice #mdr #regulation #safety #patientsafety Medicines and Healthcare products Regulatory Agency Innovate UK TOPRA - The Organisation for Professionals in Regulatory Affairs Regulatory Affairs Professionals Society (RAPS)

We've developed Element RegNav over an 18-month period, combining our regulatory expertise with generative AI technology. 💡 Our new platform aims to streamline medical device compliance planning, reducing timelines from months to weeks. 🚀 Andrew Jordan, Chief Digital and Technology Officer, states: "RegNav optimizes compliance planning and accelerates time-to-market whilst maintaining or enhancing product safety." 🏥⚡ This project kickstarts our broader digital strategy, now led by Natalie Seatter, our new VP of Digital. 🌟 Read more in our latest press release: https://ow.ly/KvBP50SE7t2 #MakingTomorrowSaferThanToday #InOurElement #ArtificialIntelligence

NEWS! Over the last few years myself, Michael Kipping and Nicole Small have been working on THE most exciting data science and artificial intelligence project within medical device safety and regulation that aims to address the problems associated with bringing-to and sustaining medical products within any modern regulatory jurisdiction. During the COVID-19 pandemic we saw the greatest ever global need for an engineered medical device (ventilators) ever - It was then I realised the complexity facing the smartest people in the world trying to understand exactly what they have to do to achieve a safe and effective medical device. I was fortunate enough to witness first hand amazing clinicians, design engineers, test engineers, quality engineers, regulatory affairs, scientists, academics working together on several products trying to develop and scale-up. The greatest issue that was faced was that engineered products need 'requirements'. Those requirements are defined in regulations, standards, guidelines, internal company know-how and all culminate into state-of-the-art. At Element RegNav we have now spent tens of thousands of hours classifying, labelling, training and ultimately developing a software solution with features that aims to navigate you through those requirements enabling you to develop and sustain safe and performing devices. This is done using the bedrock of international safety and performance requirements, known state-of-the-art and user-defined characteristics that are derived from your medical products intended use and technological characteristics. This has been an incredible journey involving colleagues that have developed medical products, regulated and tested them as well as the secret sauce - software engineers, UX engineers, DevOps, Data Scientists and some of the most dedicated and mission driven people at Element Materials Technology This is a dream come true and I invite you to join me on this exciting journey that takes us from defining our product characteristics to understanding the performance, safety, useability and functional requirements that give you confidence when creating your design and development plan and ultimately submitting to regulatory authorities, notified bodies and your own stakeholders evidence that these requirements have been addressed. Ultimately our mission is to make tomorrow safer - we've just taken a gargantuan leap with Element RegNav Michael KippingNicole Small

There is, in my humble opinion, an interesting discussion to be had around this, especially using FDA approval/clearance as the metric. 🤔 💡 The "benevolent" interpretation might be that #Radiology trailblazed the art of the possible for the use and application of #AI and other sectors have now taken the lessons and diving straight in to. More tools in other sectors means relative reduction in this one. 🔥 There is also the question to be asked about how many of the hundreds of Imaging AI tools that have regulatory clearance actually have commercial penetration and success and how many are still scrabbling around for free or funded pilots? 🌩 The basis for the latter is also (IMO) multifactorial and requires some analysis before we crank out even more Radiology AI Most likely reality lies in the shades of grey between all these convergences I would be all for fewer, more impactful and appropriate solutions that have demonstrable benefit to quality, efficiency, effectiveness enhancing the workflows not making them more cumbersome 😃 Not too much to ask for is it? 😇

🎬 𝐀𝐈 𝐀𝐂𝐓 𝐒𝐔𝐌𝐌𝐈𝐓 𝐒𝐮𝐦𝐦𝐚𝐫𝐲🎬 October 1st was a great date 😁 Again I want to thank everyone for their participation in the AI ACT Summit. It was a great success and we are proud of the team for all their effort. I wanted to create a small summary of it so you can identify some takeaways. Don't hesitate to let me know if there is something else that I should add to it. 📲 https://lnkd.in/dHwM5gaF #medicaldevice #easymedicaldevice #regulatoryaffairs #aiactsummit #aiact Easy Medical Device 4BetterDevices

Yesterday, I had the opportunity to attend the AI ACT Summit, an impressive event organized by Easy Medical Device and 4BetterDevices. The summit brought together experts from across the industry to discuss the crucial regulatory shifts ahead for medical devices integrating artificial intelligence. As the AI Act implementation deadline of August 2027 approaches, it’s clear that manufacturers need to begin preparations now to meet the evolving regulatory landscape. The discussions during the event were eye-opening, particularly on how AI will reshape compliance, technical documentation, and risk management for high-risk medical devices. You can read the summary of discussions in below post. #aiact #medicaldevices

Verification and Validation - The Cornerstone of Medical Device Success 🚀 As a physician and medical device entrepreneur, I’ve learned firsthand that building a successful medical device requires meticulous attention to safety and effectiveness. This is why verification and validation (V&V) is so crucial. It's the process of demonstrating that your device meets its intended use and consistently performs as expected. Imagine a world without V&V. Medical devices would be released without rigorous testing, potentially leading to malfunctions, inaccurate diagnoses, and even patient harm. 🏥😭 V&V, though often perceived as a regulatory hurdle, is actually a cornerstone of building trust with users and ensuring that your device delivers on its promises. 🤝 When done properly, V&V not only safeguards patients but can also accelerate your product development cycle by identifying and resolving issues early on. For AI/ML-based SaMD, V&V becomes even more critical due to the inherent complexities of these systems. We need to demonstrate that our algorithms are robust, reliable, and make accurate predictions across diverse patient populations. 🔬 So, if you're building a medical device, don't treat V&V as an afterthought. It’s an investment in patient safety, product quality, and ultimately, the success of your device. 💪

Exciting news in the world of medical technology! The FDA has introduced new guidelines to promote transparency for machine learning-enabled medical devices. Device developers now have a clear roadmap on what to share and how to share it, fostering better transparency practices across the industry. Stay informed about the latest developments in medical technology. Read more here: #medicaldevices #artificialintelligence

AI is the "hot topic" these days, regardless of industry. Understanding regulatory hurdles is crucial for the success of AI-enabled medical devices. Discover key strategies and tips from Noridian's Jeanna Blitz and Cory Hayes in this MedTech Intelligence article. #RegulatoryHurdles #AIinHealthcare

Compliance Monday’s: Medical Device Innovations You Need to Know About Dive into the Future of Healthcare! Explore the #latestinsights in cutting edge #MedicalDevice Innovations that are reshaping the industry. Stay informed and ahead of the curve in this dynamic landscape by having an idea of the latest innovations. Unlock a wealth of knowledge and stay ahead in the rapidly evolving world of medical advancements by partnering with Compliance Group Inc! Visit us at www.complianceg.com  Please send your questions to info@complianceg.com   #fda #medicaldevices #healthtech #innovationalert #healthcarerevolution #healthcarefuture #compliancesolutions #cgservices #compliancemondays #compliancegroup #regulatory #industryinsights   Explore here: https://lnkd.in/g8s8fKW3