ISO 11607-3 was published in September 2026, adding requirements for process development of heat-sealed sterile barrier systems. This column recaps parts one and two, sets out what part three adds, and covers what manufacturers should do now, from impact assessment to compliance timelines.

A practical guide to choosing a medical device regulatory consultant: how to match experience to your market and device type, what to ask in the first call, and which red flags to take seriously.

Location matters less than expertise when choosing a medical device regulatory consultant — here is what actually does.

Technical debt — a concept borrowed from software development — applies with equal force to medtech product certification, where deferred decisions and cut corners accumulate into a hidden drag on resource and commercial opportunity. Most senior leaders don't see the cost until a crisis forces the issue; the argument here is for making it visible, measurable, and planned for before that point arrives.

Why management style sets organisational risk tolerance, and how this impacts patient safety.

Regulatory affairs quietly generates competitive intelligence that most medtech businesses never use commercially.

Why medtech occupies a uniquely challenging space in this triangular paradigm.