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ALJAŽ PODBORŠEK

Director of Product Compliance

SIQ Ljubljana

Ljubljana, Slovenia

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Medical Device Compliance & Cybersecurity Auditor with 20+ yrs in QA & regulatory affairs, ensuring patient safety & secure, compliant systems.

My organisation

SIQ Ljubljana

SIQ Ljubljana

Notified body

Ljubljana, Slovenia

The Slovenian Institute of Quality and Metrology (SIQ Ljubljana) is a professional, independent, and impartial institution offering comprehensive solutions in the fields of product testing and certification, management systems assessment, metrology, and training. Established in 1964, SIQ has over 60 years of experience supporting organizations in enhancing product and service quality, increasing productivity, and achieving operational excellence
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About me

Accomplished professional with 20+ years of experience in quality assurance, regulatory affairs, and auditing in the medical device and high-tech industries. Currently a Notified Body Auditor at SIQ Ljubljana, ensuring patient safety and regulatory adherence through comprehensive audits, technical documentation reviews, and cybersecurity compliance evaluations.

Formerly Head of Quality at Cosylab, where I led global quality, regulatory, and cybersecurity initiatives across subsidiaries in Europe, the USA, and Asia. Expertise includes ISO 9001, ISO 13485, MDR, MDD, ISO 14971, IEC 62304, IEC 62366, IEC 82304, IEC 81001-5-1, ISO 27001, and CFR 21 Part 820. Strong background in risk management, QMS development, IT system validation, cybersecurity for medical devices, and lifecycle management of secure systems.

Recognized for leading cross-functional teams, strengthening cybersecurity and compliance strategies, and guiding organizations through complex regulatory and security frameworks to maintain certifications and ensure patient safety.

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Speaker sessions (1)

Wednesday, 15 October 2025

15:15 - 16:30

C1: Cybersecurity and IT security

Location:Room 1: Maria Theresia
  • Larissa Naber: The Connected Medical Device and Its Natural Enemies
  • Aljaz Podborsek: Cybersecurity of Software in Healthcare and Medical Devices - the Role of the IEC 81001-5-1 Standard
  • Nilaykumar Patel: Cybersecurity for SaMD: Cybersecurity-related Documentation in Technical File Preparation for Review by Notified Body