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This week, the discussion around clinical investigations continues to focus on one of the most important recent developments in medical device quality: the publication of the 2026 edition of ISO 14155. For inspection and quality professionals, this is welcome news. It brings renewed clarity to how clinical investigations should be planned, conducted, recorded, and reported, while keeping attention on what matters most: human safety, reliable evidence, and professional account

In medical devices, quality is never only about whether a product works. It is also about whether it works safely, consistently, and with risks reduced to an acceptable level. This is why risk management remains one of the most important parts of the medical device field. As devices become more digital, more connected, and in some cases more intelligent, the need for structured risk management becomes even stronger. That is where ISO 14971 becomes highly valuable. From the vi