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SmartEye – eQMS
Support every device class with expert guidance toward regulatory approval.
Help diagnostic manufacturers achieve compliance and faster global market approvals.
Guide medical software to compliance and successful market entry.
Navigate AI regulation confidently and bring innovation safely to market.
Stay informed with clear regulatory insights that simplify complex compliance decisions.
Learn directly from experts simplifying medical device compliance and regulation.
Explore country-specific medical device regulations, registration requirements, and market access guidance.
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Explore in-depth regulatory trends and practical guidance for medical device success.
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Issue #2 • Nov-Dec 2025
Learn how notified bodies, AI, and new standards affect your medical device processes. Apply the insights from this issue to make informed decisions and improve your compliance outcomes.
The notified body model and potential EU alternatives
Guidance on the EU AI Act for QA/RA teams
ISO 10993-1:2025 biocompatibility standard revision
Malaysia’s MDA joining MDSAP for faster approvals
Health Canada guidance for urgent public health device applications
Expert interviews on IEC 60601-1 and AI impact on QA/RA roles
Practical tips for internal audits, standards purchasing, and regulatory culture
Stay ahead of regulatory changes and industry innovations shaping medical device compliance.
