Are you a startup developing a medical device or in-vitro diagnostic device? Join this event to meet our experts and receive the latest regulatory insights, as well as guidance on the process of placing your device on the market.
This one‑day event helps MedTech startups define a clear and realistic regulatory pathway critical to funding, speed to market, and long‑term success.
We know that navigating MDR, IVDR, ISO 13485, and MDSAP certification can feel complex and overwhelming for early‑stage companies and understand the unique challenges startups face: that’s why have created this opportunity to directly interact with our BSI experts.
Beyond the learning programme, the event offers valuable opportunities to have your space to ask questions, discuss real-world challenges, and learn from others navigating the same regulatory landscape.
Why Attend?
If understanding MedTech regulatory pathways is your priority, this is exactly the event you’ve been waiting for.
We will focus on:
- Clear guidance on MDR and IVDR certification pathways – Understand timelines, expectations, and the documentation needed at every stage.
- Comprehensive Understanding and tailored approaches of SaMD, QMS & AI Regulations – Explore key compliance requirements, including clinical evaluation, risk management, cybersecurity, and software lifecycle management.
- Interacting with a Notified Body such as BSI streamline your certification pathway – Gain insights into powerful tools such as the Structured Dialogue service and dedicated interactive reviews, enabling you to engage with BSI more effectively.
- Expert insights about QMS – Understanding what to expect from a QMS audit under ISO 13485 and MDR/IVDR—from pre-certification to implementation and full alignment
- Interactive Q&A with regulatory specialists – Bring your questions and leave with concrete answers.
- Engage with BSI experts and industry peers
Who Should Attend?
- Regulatory Affairs (RA) and Quality Assurance (QA) professionals involved in submissions and compliance, and R&D teams shaping product design with regulatory requirements in mind.
- Startups entering the MedTech space and navigating certification for the first time. SMEs looking to strengthen regulatory readiness and compliance.
- All stakeholders across the startup MedTech industry looking for practical clarity and actionable guidance on their certification journey.
Speakers:
- Thomas Doerge, Global Head Active Implantable Medical Devices und SaMD
- Laura De Francesco, DACH Service Delivery Manager
- Richard Holborow, Head of Clinical Compliance
- Heike Moehlig-Zuttermeister, Principal Technical Specialist & Scheme Manager – IVD
- Saeid AmirHaftehran, AI Client Manager