A half day for MedTech startups and scale-ups preparing for clinical investigations
Join us for a hands-on morning session designed to support MedTech startups and scale-ups as they take their first steps toward clinical investigation.
Whether you’re preparing for your first-in-human study or planning your clinical strategy, this event will help you avoid common pitfalls and focus on what really matters to succeed.
You’ll hear from experienced speakers representing APNC, MediCase, TÜV SÜD, and GBA Key2Compliance – all sharing practical advice, expert insights, and real-world experience working with early-stage MedTech companies.
What we’ll cover
• Early Clinical Strategy – What must be in place before you apply for a Clinical Investigation
• Biocompatibility in Practice – Getting it right from the start, avoiding costly changes and unnecessary testing
• Study Design from a statistical perspective – From concept to statistically robust setup
• Data Collection in a clinical investigation – What you set up early saves you later
• Notified Body Expectations – What NBs expect from your clinical evidence
Exclusive for our attendees:
You can also book a personalized advisory session for tailored guidance on your specific project. Jeanette Demorney, Director Clinical Development will meet with you one-on-one to discuss your clinical strategy, study design, or any other questions. Sessions are up to one hour – simply reach out to her via email to reserve your spot and make the most of this opportunity!
Who should attend
Founders, regulatory/clinical leads, and development teams at early-stage MedTech companies, especially those preparing for first-in-human investigations or validation studies. The session is tailored for startups and scale-ups with limited in-house resources for clinical development.
Come share experiences, ask questions, and get practical guidance from experts and peers. We look forward to seeing you there!
Date: Thursday, 18th September 2025
Time: 8:00 – 11:45
Venue: GoCo House, Entreprenörsstråket 10, SE-431 53 Mölndal