Medical Device Software: Complying With The EU MDR, EU IVDR & FDA Regulations Scheduled For January 25-29, 2027, Focusing On Global Regulatory Pathways For Medical Device Software

(MENAFN- GlobeNewsWire - Nasdaq) Research and Markets has opened registration for the live online course Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations. The course is organized by IPI Academy and runs January 25-29, 2027. It gives product, regulatory, quality, engineering, and clinical professionals a practical understanding of global medical device software regulations, so they can steer software through regulatory pathways and bring it to market.

Dublin, Oct. 02, 2026 (GLOBE NEWSWIRE) -- "Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations (Jan 25th - Jan 29th, 2027)" has been added to ResearchAndMarkets.com's offering.

Key Event Facts

• Course: Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations
• Date: January 25-29, 2027
• Time: January 25th 09:00 to January 29th 17:00, GMT
• Format: Online
• Duration: 5 Days
• Focus: Medical device software regulation under the EU MDR, EU IVDR, and FDA, including clinical validation, regulatory positioning, and compliant software development

Decisions made during medical device software development directly affect the outcome of the market authorisation process. These include product claims, technology selection, and regulatory positioning. Missteps can mean costly delays, higher development expenses, or denied market entry.

Emerging technologies such as digital therapeutics, machine learning, and cloud computing have made the regulatory landscape more complex. Participants work through challenges including:

• distinguishing medical from non-medical software
• defining clinical validation needs
• understanding international regulatory differences
• meeting diverse market authorisation requirements

The course is delivered through expert-led sessions, hands-on exercises, and real-world case studies. It also covers best practices for developing and managing regulated software without stifling innovation. Participants learn how to balance flexibility in early design with the rigorous oversight needed for a final build that is safe, reliable, and fully compliant. The course carries 30 CPD hours.

A QA Coordinator at Brainomix who attended a previous edition of the course said: "I thought the content was incredibly comprehensive and very detailed. The speakers were knowledgeable and engaging."

Why You Should Attend

• Learn how product claims, technology choices, and regulatory positioning shape market authorisation outcomes.
• Distinguish medical from non-medical software and define clinical validation needs.
• Understand international regulatory differences across the EU MDR, EU IVDR, and FDA frameworks.
• Apply best practices for developing and managing regulated software through hands-on exercises and real-world case studies.
• Earn 30 CPD hours upon completion of the course.

Business Relevance

The course content applies directly to the responsibilities of teams developing and bringing medical device software to market. It supports an understanding of how early regulatory decisions affect timelines, development costs, and market access across major jurisdictions.

Who Should Attend

• Product and strategy: business strategists, product managers, and service and sales managers
• Regulatory, legal, and quality: regulatory affairs specialists and managers, legal professionals, compliance officers, and quality assurance engineers
• Engineering, development, and validation: software developers, system analysts, technical writers, biomedical engineers, clinical validation specialists, usability engineers, and risk management moderators
• Project and clinical leadership: project managers, clinical informatics managers, clinical research associates, and R&D engineers

The course runs January 25-29, 2027. Medical device software professionals should plan their participation ahead of these dates.

Featured Speakers

• Koen Cobbaert: Quality, regulatory, and standards expert at Philips.
  • Industry representation: Chairs the COCIR and DITTA software focus groups, representing industry at European Commission MDCG workgroups and the International Medical Device Regulators Forum (IMDRF) workgroup on artificial intelligence. He is also an advisor in the SaMD workgroup at the Global Harmonization Working Party (GHWP).
  • Publications: Edited the book Software as a Medical Device, published by the Regulatory Affairs Professionals Society (RAPS).
  • Experience: Holds a Master of Science in electrical engineering and safety risk management. He has over 15 years of hands-on experience establishing regulatory and market-access strategies for medical device software.
• Zuzanna Kwade: Software Clinical Evaluation Lead at Dedalus Healthcare, with a PhD in Biochemistry and 15 years of experience in clinical and medical research.
  • Clinical evaluations: Has conducted clinical evaluations under MEDDEV 2.7.1 (Rev.4) since 2016.
  • Guidance work: Represented COCIR in the European Union Task Force on clinical evaluation of software and co-authored the MDCG 2020-1 guidance on clinical evaluation of MDSW.

To reserve a place on "Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations," register your interest directly through Research and Markets at:

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