The Hardian Health Tech Summit is less than a month away... On Thursday 19th of September we’ll be hosting our 3rd annual Summit at the @ London Institute of Healthcare Engineering, bringing together top voices in healthtech, including: 🔹David Grainger from MHRA 🔹Vishal Gulati from Recode Ventures 🔹Hannah Richardson (née Murfet) from Microsoft Research 🔹Key representatives from NICE, NHS SBS, and BSI. Join us for an exclusive afternoon of expert insights into the rapidly changing world of healthtech regulation and market access for SaMD and AIaMD. Missed your chance to grab a ticket? Join the waitlist, and we’ll keep you posted if a spot opens up ➡️ https://lnkd.in/eQ2_-zGu Stay in the loop by subscribing to our newsletter for updates and future events ➡️ https://lnkd.in/eaF6MMWs #HardianHealth #Regulation #Startups #HealthTech #DigitalHealth
Hardian Health
Business Consulting and Services
Haywards Heath, England 3,120 followers
Clinical | Digital | Consulting
About us
We help researchers, industry and investors bring digital solutions to healthcare.
- Website
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http://www.hardianhealth.com
External link for Hardian Health
- Industry
- Business Consulting and Services
- Company size
- 11-50 employees
- Headquarters
- Haywards Heath, England
- Type
- Privately Held
- Founded
- 2018
- Specialties
- medical devices, SaMD, regulation, health economics, intellectual property, clinical trials, scientific publication, due diligence, and AIaMD
Locations
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Primary
21 Perrymount Road
Haywards Heath, England RH16 3BA, GB
Employees at Hardian Health
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Stephen Carter
Intellectual Property strategy & management for technology start-ups and scale-ups | 'Investment ready' IP strategy aligned with business goals |…
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Mike Pogose
Director of Quality Assurance and Regulatory Affairs at Hardian Health — Innovation Management | Non-Executive Director | Quality Assurance |…
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Sarah Bell
Operations Manager at Hardian Health | She/Her/Hers
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Shirley Bonta
Operations and Projects Lead
Updates
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We're building something exciting, and are looking for a full stack dev to join our team. Front-End: Strong proficiency in HTML, CSS, JavaScript, and modern frameworks such as React, Angular, or Vue.js. Back-End: Strong experience with Python backend (Django/Flask), Databases: Experience with relational databases (i.e, PostgreSQL). https://lnkd.in/eVPQWeVh #fullstack #developer #job #careers
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Are you on the right path to certifying your medical device? In the journey to regulatory approval, both Quality Management System (QMS) certification and AI validation play critical roles – each covering essential aspects of your medical device's compliance and safety. A QMS ensures your processes meet regulatory standards throughout your device's lifecycle and AI validation ensures your AI components are trained and tested with high-quality data with multiple labellers. Not sure where to start? Contact the Hardian team today to leverage our deep knowledge and tested strategies! ➡️ https://lnkd.in/ecUMAN9t #HardianHealth #Regulation #Startups #HealthTech #DigitalHealth
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🧭 The regulatory roadmap for AI needs clearer directions… The Health Foundation’s latest report highlights a pressing concern – AI in healthcare is advancing, but without a clear and coordinated strategy, the NHS could face significant challenges. With mounting pressures on healthcare systems, the report stresses the urgent need for a strategy that includes better clarity on the UK’s regulatory framework for AI. Without this, fragmented efforts could exacerbate inequalities and hinder effective implementation. AI’s potential is significant, but so are the risks. A comprehensive strategy is essential to navigate these complexities and ensure AI is used responsibly and effectively across the NHS. For more on the future of AI in healthcare, read the full report here ➡️ https://lnkd.in/eY7WjSwd Keep up with the latest in AI healthcare by subscribing to our newsletter ➡️ https://lnkd.in/eaF6MMWs #HardianHealth #Regulation #Startups #HealthTech #DigitalHealth
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Hardian Health reposted this
The Hardian Health Tech Summit is now SOLD OUT. If you'd like to get on the waitlist, simply leave your email at the registration page, and we will let you know if a ticket becomes available. Don't want to miss out next time? Sign up to our newsletter: https://lnkd.in/eaF6MMWs https://lnkd.in/eQ2_-zGu
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Want to outshine your competitors? Well, you need a robust pre-market competitive analysis! By evaluating your competitors' products, services, and go-to-market strategies, you can identify their strengths and weaknesses relative to your own. This is essential for your product development and launch strategy, helping you articulate your competitive advantage, shape your value proposition, and refine your pricing strategy. Start by gathering comprehensive information on current and potential competitors, including product profiles, performance, and pricing strategies and then use these insights to differentiate yourself. Not sure where to start? Contact the Hardian team today to leverage our deep knowledge and tested strategies! ➡️ https://lnkd.in/ecUMAN9t Learn more about pre-market competitive analysis ➡️ https://lnkd.in/e4Q7VGTX #HardianHealth #Regulation #Startups #HealthTech #DigitalHealth
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The Hardian Health Tech Summit is now SOLD OUT. If you'd like to get on the waitlist, simply leave your email at the registration page, and we will let you know if a ticket becomes available. Don't want to miss out next time? Sign up to our newsletter: https://lnkd.in/eaF6MMWs https://lnkd.in/eQ2_-zGu
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How can you secure value in your business through intellectual property? Understanding your company’s current position and ownership assets is essential. Stephen Carter, our Senior Consultant on Intellectual Property underlines that the first important step is an IP audit. This can be a light touch or an in-depth analysis, depending on your needs. By evaluating your existing IP assets, ownership status, and related agreements, we ensure everything is in place for your business's growth. We also forecast future asset creation to capture and protect new IP effectively. If you need support with your IP strategy, contact Hardian today to safeguard your business's future. ➡️ https://lnkd.in/ecUMAN9t Listen to Stephen explain further ⬇️ #HardianHealth #Regulation #Startups #HealthTech #DigitalHealth
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Keep calm, and don't forget to carry out your post-market clinical follow-up… Post-market clinical follow-up (PMCF) is a systematic, proactive, and documented process where medical device manufacturers collect clinical data based on the intended use of their devices. The goal is to confirm the clinical performance and safety of the device throughout its lifecycle while it is on the market. PMCF also helps determine the acceptability of identified risks and detect emerging risks based on factual evidence. This continuous monitoring is crucial for ensuring ongoing patient safety and regulatory compliance. By gathering and analysing real-world data, manufacturers can address any potential issues early and maintain the high standards required for medical devices. Find out more ➡️ https://lnkd.in/eqSjhTaw #HardianHealth #Regulation #Startups #HealthTech #DigitalHealth
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It goes without saying that strategic planning is crucial for both regulatory approval and market success. We cannot underestimate the key role that both a Minimally Viable Product (MVP) and a Minimally Marketable Product (MMP) play in achieving market success. Believe it or not, understanding your target market should happen before you begin your regulatory journey. An MVP ensures essential regulatory certification by focusing on safety and effectiveness, while an MMP builds on the MVP by adding market-specific features, making your product attractive to buyers and valuable to users. In our latest blog, our Director of Quality Assurance and Regulatory Affairs, Mike Pogose, delves into: 🔹 The importance of MVP and MMP 🔹 The right time to start MVP and MMP evaluations 🔹 How to make a successful transition from MVP to MMP While it’s easy to focus solely on gaining regulatory approval, failing to consider market fundamentals at the same time can lead to issues down the line. Want to know more? Read the full blog ⬇️ https://lnkd.in/eaetNZ8W For expert guidance on MVP and MMP strategies, contact the Hardian team today ➡️ https://lnkd.in/ecUMAN9t #HardianHealth #Regulation #Startups #HealthTech #DigitalHealth