About this Event
BSI x LIHE: Empowering the Future of MedTech Innovation to BSI and LIHE
BSI, a leading Notified Body, is at the forefront of supporting MedTech innovators as they navigate the complex landscape of regulatory requirements. With deep expertise and a steadfast commitment to quality, BSI empowers companies to bring compliant and safe medical technologies to market efficiently and confidently.
Recently, BSI has partnered with LIHE, combining their strengths to further enhance support for MedTech organizations. This collaboration aims to streamline regulatory processes and accelerate innovation — ultimately helping bring life-changing medical solutions to patients faster.
We are proud to extend this partnership to include the youngest innovators, early adopters, and a renowned academic institute, uniting fresh perspectives with world-class expertise to drive the next generation of MedTech breakthroughs.
Topics discussed during the event, presented by BSI’s experts:
• Implementation of a Quality Management System (QMS) – David Kemp, Service Delivery Manager - UK
• Technical documentation for MDR and UKCA accreditation: content, preparation, and common causes of delays for manufacturers ) –Tim Marriott, Technical Team Manager – Orthopaedics and Dental
• Post-Market Surveillance (PMS) – Nicholas Harbord-Smith, Senior Clinical Evaluations Specialist
• The EU AI Act - ISO 42001 - Ehsan Nadernejad, AI Technical Specialist
Meet and connect with BSI's experts and commercial team and learn more about regulatory challenges and key topic and network opportunities.
Not only a learning program but also a network space where innovators can interact with peers in the medical device community to ask questions and address challenges being faced when navigating the regulations.
Join this event if you are a Medtech startup, innovator, product manager or clinical entrepreneur looking to learn more information about MDR, IVDR, ISO 13485, UKCA and AI.
Why Attend?
🔹 Engage with BSI experts and industry peers
🔹 Learn more about QMS, Technical Documentation, Post Market Surveillance for your journey to MDR and UKCA certification
🔹 Discover AI Act and ISO 42001
🔹 Discover how working with a Notified Body like BSI can streamline your certification journey
This event is designed to foster knowledge sharing, collaboration, and actionable insights, supporting startups in achieving regulatory compliance and a successful path to market.
📢 Register now and take the next step in your MedTech Startup journey!
Participation Fee
This event is free of charge.
Contact
Any questions regarding this event? Please contact:
- Shaheena Afini (Business Development Manager) at [email protected]
- Marjolein van Diest (Marketing Executive Benelux & Nordics) at [email protected]
- Ferdinando Lamagna (Marketing Manager Medical Devices EMEA) at [email protected]
Topics
🕑: 10:00 AM - 10:15 AM
Welcome & Introduction
Host: BSI
🕑: 10:15 AM - 11:00 AM
Implementation of a Quality Management System (QMS)
Host: David Kemp, Service Delivery Manager
🕑: 11:00 AM - 11:45 AM
Technical documentation for MDR and UKCA accreditation: content, preparation.
Host: Tim Marriott, Technical Team Manager
🕑: 11:45 AM - 12:00 PM
A Startup's Regulatory Journey – real life experience
Host: Announced soon
🕑: 12:00 PM - 01:00 PM
Lunch Break/Networking
🕑: 01:00 PM - 01:45 PM
Post-Market Surveillance (PMS)
Host: Nicholas Harbord-Smith, Senior Clinical Specialist
🕑: 01:45 PM - 02:30 PM
The EU AI Act & ISO 42001
Host: Ehsan Nadernejad, AI Technical Specialist
🕑: 02:30 PM - 03:00 PM
Panel Discussion
Host: All speakers
End of the meeting
Event Venue & Nearby Stays
London Institute for Healthcare Engineering - LIHE, 100 Lambeth Palace Road, London, United Kingdom
GBP 0.00











