From Innovation to Market: Regulatory Pathways for MedTech Innovators
Bringing MedTech innovations to market starts with understanding the regulatory landscape.
This event, developed in collaboration between BSI and the London Institute for Healthcare Engineering (LIHE), is designed to help MedTech startups and innovators understand the MedTech regulatory framework and navigate the conformity assessment journey with more confidence.
About the event
Whether you're developing your first medical device or scaling an existing product, getting to grips with the regulatory landscape is one of the biggest challenges you'll face. This event is designed to help you do exactly that.
Join BSI, a leading Notified Body and Approved Body, and LIHE, King's College London's Collaborative Centre of Excellence for MedTech translation, for a practical programme built around the key topics that matter most to you, from building a Quality Management System to understanding what's involved in the conformity assessment process.
You'll hear directly from BSI specialists with deep experience across the medical device certification landscape. You can engage with peers facing similar challenges and experts prepared to discuss the regulatory requirements shaping your route to market. And you'll leave with a clearer understanding of what it takes to bring your innovation to market compliantly and efficiently.
This isn't a lecture. It's a space where you can ask questions, test your thinking and build connections with fellow innovators, researchers and entrepreneurs in the MedTech community.
Why Attend?
- Build your regulatory knowledge: hear from BSI specialists on the key requirements for MDR, ISO 13485 and AI-related compliance;
- Understand the conformity assessment journey: learn how working with a Notified Body and Approved Body fits into your route to market;
- Explore key regulatory topics: from Quality Management Systems and technical documentation to emerging areas such as AI in medical devices;
- Connect with industry peers: meet fellow MedTech innovators, researchers and entrepreneurs facing similar challenges;
- Network in a purpose-built environment: LIHE is located in a building dedicated to bringing MedTech innovations to patients and the market.
Who Should Attend?
- MedTech startup founders and co-founders;
- Product managers and engineers working on medical devices;
- Clinical entrepreneurs and researchers;
- Quality and regulatory professionals at early-stage companies; and
- Anyone looking to deepen their understanding of MDR, IVDR, ISO 13485 and AI-related regulations.
You can book a 1-to-1 meeting with a representative of our team.
Up to 2 participants per company will be admitted to the event to allow diversified companies to participate and engage.
What to expect?
- Insightful presentations– BSI's regulatory experts share knowledge on navigating MedTech compliance.
- Interactive Sessions – Direct engagement with regulators to clarify expectations and address compliance concerns.
- Network with Industry Peers – Connect with like-minded startups and key stakeholders in the HealthTech ecosystem.
About BSI
BSI is the UK's National Standards Body and a full-scope Notified Body and Approved Body for medical devices. We work with organisations across the MedTech sector, providing conformity assessment services that help manufacturers demonstrate compliance with regulatory requirements including the EU Medical Devices Regulation (MDR), In Vitro Diagnostic Regulation (IVDR) and the UK Conformity Assessment (UKCA) marking.
About LIHE
The London Institute for Healthcare Engineering (LIHE) is a Collaborative Centre of Excellence from King's College London, established with support from Research England. LIHE focuses on the commercial and clinical translation of promising medical technologies, working alongside leading NHS Trusts, industry partners and investors to help de-risk and accelerate MedTech ventures from early stage to market.
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