Psephos Biomedica

Unlock Global Market Access: Navigating US FDA and EU CE Marking Join Psephos Biomedica for an insightful half-day workshop designed to demystify the path to #regulatory #compliance for your products. In today’s competitive landscape, understanding the nuances of submitting your medical devices to key regulatory bodies like the US FDA and achieving compliance with the EU CE marking is essential. Workshop Highlights: 🔷 US Regulatory Pathways: Gain a comprehensive understanding of the FDA’s compliance requirements—learn about the pathways to bring your medical devices to the US market, including necessary Quality Management Systems (QMS) and technical documentation. 🔷 EU Regulatory Insights: Explore the CE marking process, routes to compliance and the documentation you need for success in the European market. ** This event is now certified by The CPD Group** Join Robin Stephens and Jamie Foster of Hill Dickinson Health Lawyers to find out how to achieve regulatory compliance for your medical device and what you need to do in order to submit to a Notified Body and the FDA. Date: Tuesday 1st April 2025 Times: 13:00 - 16:00 Venue: Hill Dickinson Offices, Primrose Street, London, EC2A 2EW Cost:  FREE to attend As spaces are limited, don't miss your chance to register and gain valuable insights! 👉 https://bit.ly/4flUEJU #innovators #smes #startups #medtech #medicaldevices #healthtech #regulations #lifesciences #digitalhealth #medicaldevicemanufacturers

Absolute privilege to be on a panel today in Queen Mary University of London on behalf of Psephos Biomedica, alongside Ambika Pugalia , Nick Widdowson and Jonathan Taylor, discussing the regulatory landscape and IP, with a focus on AI healthtech, Barts Life Sciences Hill Dickinson LLP Jamie Foster, Boult Wade, S.L. A huge thank you to the wonderful audience for their fantastic engagement & interactions. Thank you so much Pargol Esfahani & Sarah F. from Barts Life Sciences #medicaldevices #SaMD #healthtech #DigitalHealth #ai

With high growth forecast for women’s health technology, it’s an attractive area for innovation. But joining the dots between concept development and commercial returns is not easy. Erica Kantor, Head of Women’s Health at Sagentia Innovation and Robin Stephens, CEO and Co-Founder of medical device regulatory consultancy Psephos Biomedica have identified five critical factors for women’s health technology commercialisation that apply to start-ups and the innovation teams of established medical industry players alike. Read the insight here: https://lnkd.in/ef2TWb2e #WomensHealth #FemTech #Science #Medical

🚀 Join Us for our Final NHS Navigation Day 🚀 After a series of impactful events over the past 18 months, we will be running our final NHS Navigation day in February - in person at Queen Mary Enterprise! 🌟 This event is an opportunity for HealthTech SMEs and Innovators to gain practical insights and guidance on navigating the complexities of the NHS and advancing your HealthTech innovation. All sessions are delivered by industry experts. 💡 Key Topics Include: The NHS landscape Regulation Intellectual Property Health Economics Sustainability NHS business cases NHS procurement Whether you're refining your market strategy or preparing for procurement conversations, this day is designed to provide you with actionable knowledge and valuable connections. 📅 Save the Date: February 18th 2025 📍 Location: Queen Mary Enterprise (Lecture Theatre and Foyer) Don’t miss out on this final chance to join our expert-led sessions and connect with peers in the HealthTech space! 👉 Sign up here: https://lnkd.in/ekpy2eCg #HealthTech #NHS #HealthcareInnovation #AI #MedTech #HealthEconomics #BusinessCases #UKscience Barts Health NHS Trust Queen Mary University of London The HealthTech SME project is supported by the UK Shared Prosperity Fund and the Mayor of London. Malachy Finnegan Sarah F. Pargol Esfahani Irfan Hassan Jamie Foster UCLPartners Nick Widdowson Claudia Rees Jonathan Taylor Lisa Cummins

Innovate UK is pleased to announce a £6.2 million investment across seven Centres of Excellence for Regulatory Science and Innovation (CERSIs) to help drive advancements in healthcare. Backed by up to £1 million each, these CERSIs will tackle key challenges in regulatory science, in areas such as Advanced Therapies, Precision Medicines, Digital Healthcare, Drug Discovery and Diagnostics. Over the coming year, the CERSIs will develop tools, frameworks, and guidance to help shape the development and approval of medical innovations in the UK. 📈 For example, a project led by Brunel University of London, aims to revolutionise regulation to bring more AI-powered healthcare products to the UK. These include diagnostics, devices which predict and treat ill-health, software which makes physical devices work, and smartphone apps. The seven funded projects set to driving safer, faster, and more innovative healthcare solutions are: - Digital Transformation of Medicines Development and Manufacturing, led by University of Strathclyde, to accelerate the adoption of digital tools in medicine development. - The UK Regulatory Innovation Network for Advanced Therapies, led by Cell and Gene Therapy Catapult, to streamline regulation of Advanced Therapy Medicinal Products. - Regulatory Science Empowering Innovation in Transformative Digital Health and AI, led by Brunel University of London, to safely maximise the potential of AI-powered healthcare solutions. - Centre of Excellence on In-silico Regulatory Science and Innovation, led by The University of Manchester, to integrate evidence from computational models into the regulatory process. - Clinical Evaluation & Assessment for Regulation of Diagnostic tests, led by Psephos Biomedica, to help create safe availability of diagnostic tests for patients. - Centre of Excellence for Regulatory Science and Innovation in AI & Digital Health Technologies (CERSI-AI), led by University of Birmingham, to optimise the regulation of AI and digital healthcare technologies to ensure innovations are safe and effective for patients. - Centre for Excellence in Regulatory Science and Innovation in Pharmacogenomics, led by University of Liverpool, to develop guidelines for using pharmacogenomics in practice, and attract further investment in this area. Read the full story here: https://ow.ly/Bj8K50UOu9o