Advancing Information Security and Privacy: The Key Steps in Applying the ISO 27k Framework

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Software Design for Medical Devices

12 min read ยท Apr 15, 2026

Advancing Information Security and Privacy: The Key Steps in Applying the ISO 27k Framework

Key steps in applying the ISO 27k framework and the importance of safeguarding your existing legacy products. The medical device industry is ever changing and evolving, especially in recent years with adjustments to regulations and the implementation of new standards. In this exclusive interview Patrick Reichmann, Quality Assurance & Regulatory Affairs Manager at Agfa HealthCare, speaks to Pharma IQ about the main challenges being faced by companies in regulatory affairs and what he thinks will be the major trends in the regulatory side of medical device software in the next couple of years.

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