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
Clinical Strategy and Preparing for a Clinical Investigation – What Needs to Be in Place
Anna Sahlholm, GBA Key2Compliance
Biocompatibility in Practice – Getting it Right from the Start
Kristina Fant, GBA Key2Compliance
Study Design from a Statistical Perspective – From Concept to a Statistically Robust Setup
Aldina Pivodic, APNC
Data Collection in a Clinical Investigation – What You Set Up Early Saves You Later
Niklas Svensson, MediCase
What the Notified Body Expects from Your Clinical Evidence
Maj Kornø, TÜV SÜD
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, 18 September
🕗 Time: 08:00–11:45
📍 Location: GoCo, Gothenburg
🎁 Cost: Free of charge
Hosted by: GBA Key2Compliance
With expert contributions from: APNC, MediCase, and TÜV SÜD
Speakers
Anna Sahlholm
Clinical Operations Manager and Senior Consultant, GBA Key2Compliance
Anna has more than 15 years of experience from product and process development in close collaboration with research and within the medical device industry. Anna has worked with research, product development, strategic product management, clinical evaluations, processes for traceability, risk management, quality, and regulatory compliance for a variety of products. What drives her is supporting companies in launching safe and effective products so that people who need them can access the medical devices they rely on.
Kristina Fant, PhD, ERT
Kristina is a toxicologist and biocompatibility expert with more than 14 years of experience of performing biological evaluation of medical devices, including a decade of hands-on work in the lab. She is active in standardization in ISO TC 194. Kristina has special interest in replacing animal testing with alternative testing methods (NAMs), and is a delegate of the Swedish National Committee for the protection of animals used for scientific purposes, steering group for the Swedish 3Rs center.
Aldina Pivodic
Aldina is an experienced statistical consultant with more than 20 years of hands-on expertise in medical research, data analysis, and writing and reviewing impactful medical publications. Her passion lies in using data-driven insights to advance clinical research and improve healthcare outcomes. Aldina is the CEO of the company and holds a position as Senior Statistician.
Niklas Svensson
Maj Kornø
Maj is a Medical Doctor and Senior Consultant in Orthopedic Surgery, certified in MDR. At TÜV SÜD, she works as an Internal Clinician, focusing on the clinical assessment of certification applications under MDR. She also supports clinical processes and communication, helping to clarify MDR requirements and the role of the notified body.
