Medical Device Compliance Seminar

Join us for a full-day Medical Device Compliance Seminar bringing together industry experts, regulators, notified body professionals, and manufacturers to address the most pressing challenges in the field of medical device certification.

The programme covers the latest MDR updates, risk management, sterilization, biocompatibility requirements under ISO 10993-1, the impact of new AI Act, as well as requirements related to post-market surveillance (PMS) and clinical evaluation. It also includes panel discussions with industry representatives and notified bodies, providing an opportunity to exchange practical experiences and address the most common challenges encountered in practice.

In the afternoon, under the theme “Expertise creates Safety,” distinguished speakers and guests will reflect on the broader role of expertise, responsibility, and trust in today’s society.

Participants may also extend their conference experience to Day 2 (28 May) and join the Medical group of the 9th Safety and EMC Seminar, featuring in-depth sessions on IEC 60601-1-2 updates, EMC debugging, international approval challenges, electrical safety testing, and practical EMC workshops.

The seminar fee includes participation in all sessions, materials, meals, and social activities.

26 May	Dinner for the participants arriving on Tuesday (optional)
27 May	Seminar Day 1 – Medical Device Compliance Seminar
28 May	Seminar Day 2 – 9th Safety and EMC Seminar (MED) (optional)

Day 1, 27 May

Morning Sessions

[9.00–14.40, Glass Hall]

• 9.00–9.10 Peter Kramar, PhD | Welcome and Introduction
• 9.10–9.30 Ana Pribaković Borštnik, MSc | MDR Update
• 9.30–10.10 Uroš Tacar, Matej Kranjec, PhD | From Development to Compliance
• 10.10–10.45 Discussion panel | The Path to the CE Mark (M2Call Aps, Denmark: Michael Lange & Polident, Slovenija: Beate Pečečnik, MSc)

10.45–11.00    coffee break

• 11.00–11.20 Rok Hrovatin, PhD | Risk-Based Approach in Medical Device Production
• 11.20–11.40 Marjetka Kralj Kunčič, PhD | Sterilization Compliance: What Auditors Care About?
• 11.40–12.00 Marina Daineko, MSc | What’s New in ISO 10993-1 and What it Means for Medical Device Manufacturers?
• 12.00–12.00 Marjeta Tušek Jelenc | Impact of the New AI Act on Medical Device Manufacturers
• 12.20–12.30 Questions & Answers

12.30–13.30     lunch

• 13.30–13.50 Tibor Zeichmeister, MSc | PMS, Vigilance, and Trend Reporting – Essentials Every Manufacturer Need to Know
• 13.50–14.30 Discussion panel (Aleksandra Burgić, MD; Rade Pribaković Brinovec, MD; Ana Pribaković Borštnik, MSc) | Clinical Evaluation Assessment: Challenges and findings
• 14.30–14.40  Questions & Answers

Afternoon Sessions

[15.00–16.40, Grandis Hall]

Expertise Creates  Safety

• Introduction: Gregor Schoss, Managing Director, SIQ Ljubljana
• Aljoša Petek |The Independence of Expertise as Seen by the Public
• David Zupančič, MD | The Challenges of Finding the Work-Life Balance in Today’s World
• Round table | Strength Through Support – The Family of Tadej Pogačar 
  • Discussion: Mirko Pogačar, Marjeta Pogačar, Tilen Pogačar
• Musical Support: Bassless

[17.00–22.00, Duck’s Island] Afternoon activities

Day 2, 28 May (optional)

EXTEND THE CONFERENCE and join the MEDICAL group on Day 2 of 9th Safety and EMC Seminar

MED/MEAS

• Upcoming Changes in IEC 60601-1-2 | New EMC Tests and What to Prepare from Now on | Damjan Repar (SIQ)
• EMC Debugging for Electrical Devices | Root Cause Analysis and Practical Mitigation Techniques | Mitja Rozman (SIQ)
• Latest Updates from IEC TC66 (IEC 61010 series) and IEC TC 62 (IEC 60601 series) | What’s New in Laboratory & Industrial Equipment and Medical Electrical Standards | Matej Šmidovnik and Janez Vidmar (SIQ)
• Evaluation of Accessible Parts in Medical Equipment 
• Challenges During International Approvals – Additional Technical Requirements | Matej Šmidovnik, Janez Vidmar (SIQ)
• Using ITAV Power Supplies in Medical Applications | Acceptance Criteria, Limitations, and Compliance Strategies | Janez Vidmar (SIQ)