Hardian Health

Are your medical devices working as they should? The FDA wants to hear all about it…👀 In the world of healthtech regulation, Medical Device Reporting (MDR) is a postmarket surveillance tool the FDA uses to keep tabs on the performance and safety of medical devices. Why does this matter? Well, MDR acts as an early warning system for detecting issues. It’s a way for manufacturers, healthcare professionals, and patients to report any incidents or problems linked to a device, which in turn informs the FDA's benefit-risk assessments. MDR reporting helps regulators monitor potential safety concerns and manufacturers to act swiftly – whether that means updating labelling, improving designs, or, in some cases, recalling products. In essence, MDR ensures devices on the market are held to rigorous safety standards, prioritising patient protection. Find out more ➡️ https://lnkd.in/e4Hxx2n2 #HardianHealth #Regulation #Startups #HealthTech #DigitalHealth

🎙️ Our MD Dr Hugh Harvey, recently joined Haris Shuaib, CEO at Newton's Tree, on the inaugural episode of 'Unfiltered: AI Leadership" to talk about all things AI in healthcare. They explored many of the opportunities and challenges AI medical device developers face, as well as: 🔹 Where VC investments are flowing (and whether they should be) 🔹 The future applications of AI in healthcare, from diagnostics to workforce transformation 🔹 Medical device regulation: what’s working, what’s not, and where we’re headed 🔹 Practical advice for medtech entrepreneurs navigating regulatory pathways Sounds like a conversation you'd be interested in? Listen to the full podcast on YouTube ⬇️ https://lnkd.in/e4v8kZbA #HardianHealth #Regulation #Startups #HealthTech #DigitalHealth

It’s easy to get swept up in the excitement around AI’s role in healthcare; however, it’s important that safety always comes first. Elon Musk’s recent invitation to submit medical images to xAI's chatbot Grok for analysis raises some serious concerns. Marketing an unregulated AI tool for medical image analysis is, quite simply, illegal. More than that, it sets a dangerous precedent for healthcare technology. AI models intended for medical diagnosis must undergo rigorous regulatory review to ensure they meet clinical standards and don’t compromise patient safety. While AI can be beneficial in many ways, unregulated use in medical settings is a dangerous shortcut. Let’s ensure that innovation in healthtech is paired with the responsibility it demands. Read the full article ➡️ https://lnkd.in/ePtGfMcs For support navigating compliant AI development, explore Hardian’s regulatory services ➡️ https://lnkd.in/ehrRuaa6 #HardianHealth #Regulation #Startups #HealthTech #DigitalHealth

The regulatory landscape for AI in medical devices is complex and constantly evolving. If only there were experts to simplify it for you...👀 We’re often asked, “What are the essential standards we need to know?” In our latest blog, our MD, Dr Hugh Harvey, provides an overview of the key standards for AIaMD, covering both foundational standards and those offering AI-specific guidance to help you stay compliant. From ISO 13485 for quality management to guidance on managing AI-specific risk management and data quality, this blog tackles it all. Get the full breakdown here ➡️ https://lnkd.in/eGsPwXHk Need tailored regulatory support for your AIaMD project? Connect with Hardian’s experts ➡️ https://lnkd.in/ehrRuaa6 #HardianHealth #Regulation #Startups #HealthTech #DigitalHealth

Who are the gatekeepers of ethical research? Enter Institutional Review Boards (IRBs). When it comes to biomedical research involving human subjects, IRBs are the ones making sure everything is above board. Designated under US FDA regulations, they review and monitor studies to ensure participants’ rights, safety, and well-being are protected at all times. From clinical trials for new medical devices to drug studies, IRBs dive deep into consent forms, study protocols, and risk management to make sure ethical standards are upheld. No IRB approval? No research. Simple as that. They’re the unseen forces safeguarding ethics while allowing innovation to move forward responsibly. #HardianHealth #Regulation #Startups #HealthTech #DigitalHealth

When navigating complex regulatory landscapes, meticulous attention to detail is a non-negotiable… Just ask Envisionit Deep AI®'s CEO, Jaishree Naidoo, who credits Hardian’s expertise in both clinical and technical strategy as key to securing their FDA 510(k) clearance. By aligning with Envisionit from the outset, we helped build a solid regulatory framework and QMS, tailored to meet the intricate demands of the process. This not only shaped their compliance but enhanced their market positioning and evaluation process – ensuring everything from development to approval stayed on course. Listen to Envisionit’s CEO Jaishree Naidoo explain more ⬇️ Need expert guidance on regulatory frameworks? Get in touch ➡️ https://lnkd.in/evRYcvJZ #HardianHealth #Regulation #Startups #HealthTech #DigitalHealth

There’s been plenty of conversation recently about validating AI health tools 👀 A recent Nature article suggests that not all AI health tools with regulatory authorisation are clinically validated and proposes a new validation standard to evaluate FDA authorisation as an indication of clinical effectiveness in medical AI tools. While this makes for alarmist headlines, here at Hardian, we think it’s important to clear up a few things: 1️⃣ The FDA wouldn’t authorise a device without proper review of clinical evidence 2️⃣ The publicly available summaries aren’t written by the FDA, but by manufacturers – and they’re not required to include clinical validation details 3️⃣ This isn’t an AI-specific issue. Lack of transparency in clinical trial data has been a broader concern for years across medical devices and drugs So, if someone claims that FDA-approved AI tools aren’t validated, gently remind them it’s not a question of validation - it’s a question of transparency. Read the full article ➡️ https://lnkd.in/gZ4uGGCd If you’d like to stay up to date with all things AI and regulation, sign up to the Hardian newsletter ➡️ https://lnkd.in/eaF6MMWs #HardianHealth #Regulation #Startups #HealthTech #DigitalHealth

Did you miss the third annual Hardian Healthtech Summit? Last month, we gathered some of the brightest minds in healthtech at the @ London Institute for Healthcare Engineering for an afternoon packed with insight, collaboration, and a bit of networking. From navigating the venture capital landscape to tackling the regulatory hurdles for AI in medical devices, our summit delivered valuable lessons for startups and innovators. If you missed the insights from industry leaders Vishal Gulati from Recode Ventures, Inma Pérez Ruiz from BSI, Hannah Richardson (née Murfet) from Microsoft, David Grainger from Medicines and Healthcare products Regulatory Agency, Farhan Ismail from NICE - National Institute for Health and Care Excellence, and Hamza Hussain from the NHS Shared Business Services, we've summarised our reflections in our latest blog. We cover: 🔹How to secure funding in a challenging VC landscape 🔹Navigating the EU AI Act for medical devices 🔹The initiatives public bodies are developing to keep pace with rapidly evolving digital technologies 🔹The evolving risks of generative AI in healthcare 🔹A closer look at the UK's Innovative Devices Access Pathway (IDAP) If you would like to attend our event next year - only our newsletter subscribers can get tickets, so sign up now.! https://lnkd.in/eaF6MMWs Read the full blog to catch up on all the details: https://lnkd.in/ekBRf-Ry #HardianHealth #Regulation #Startups #HealthTech #DigitalHealth

What exactly is eIFU, and why should you care? The term stands for Electronic Instructions for Use – a regulation that governs how instructions for medical devices are provided to users. These instructions explain everything from how the device should be used, to its intended purpose, and any important safety precautions. Under EU regulations, manufacturers can offer instructions digitally but here’s the catch: a paper copy must be available upon request. This flexibility allows for easier access to information while maintaining user-friendly options for those who prefer physical documentation. For manufacturers, offering both formats ensures compliance and improves accessibility for users – making it easier to meet regulatory demands while prioritising the end-user experience. Not sure where to start? Get in touch to discuss how Hardian Health can help ➡️ https://lnkd.in/ecUMAN9t #HardianHealth #Regulation #Startups #HealthTech #DigitalHealth

Quality Management Systems – demystified! ⬇️ We’ve broken down everything you need to know about QMS. Mike Pogose, our Director of Quality Assurance and Regulatory Affairs, gives you the essentials – what a QMS really is, why it’s non-negotiable, and how to set one up without the headaches. Whether you're developing SaMD, AIaMD, or gearing up for regulatory approval, get the lowdown on building a compliant, effective QMS tailored to your needs. Curious about what’s involved? Check out the full blog and get started on streamlining your quality processes: https://lnkd.in/eYu5dC8Z #HardianHealth #Regulation #Startups #HealthTech #DigitalHealth