Welcome to Hattrick's Healthcare Musings, where innovation meets insight in the ever-evolving landscape of healthcare software development.
A bug gets reported. Someone reproduces it. Someone fixes it. Someone closes the ticket. Somewhere in that sequence, four regulated decisions happened. Most teams can't tell you where. Was this a defect or expected behaviour? Does it affect safety? Where does the fix re-enter
Diligence rarely fails on the device. The device works. The bench data is good. The clinical story holds up. Then a request list arrives, and somewhere between item fourteen and item twenty-two there are five or six lines about software documentation — and that is
Most founders building an AI-enabled device have heard the term Predetermined Change Control Plan by now. It shows up in every panel about SaMD regulation, every FDA guidance recap, every “what's new in medtech regulatory” newsletter. On the other hand, founders building a non-AI
We've written about IEC 62304 clauses before, Clause 6 (maintenance, back in June) and Clause 8 (configuration management, in August). But what about Clause 7? Clause 7 might be the most skipped clause in the whole standard. Not because it's obscure, because most teams
Last month we wrote about Clause 6 — the maintenance process that turns every post-clearance commit into a regulated event. One of the five failure patterns we flagged was maintenance branches that drift: a hotfix ships, "we'll merge it back next sprint" goes in the
Most teams building Software as a Medical Device (SaMD), digital therapeutics, or device-connected software run sprints. Most of them are also making one of three mistakes that break their IEC 62304 compliance — and they don't usually find out until submission prep. Check out our
Every founder preparing a 510(k) eventually finds a checklist online. Some are six items. Some are sixty. Most are structured around device type, not software content, which means they miss the things that actually cause software-heavy submissions to stall. This is not that
In February 2026, FDA's Quality Management System Regulation (QMSR) replaced 21 CFR Part 820, the Quality System Regulation that governed medical device manufacturing for almost three decades. The headlines were relatively quiet. That is partly because QMSR was designed to harmonize FDA requirements with
At Hattrick IT, we have taken over mid-development of medical device software projects. The most complex involved a project where a previous vendor had failed to deliver, leaving a partially built codebase with significant compliance gaps. We completed the project and supported the FDA
The tension between moving fast and staying compliant keeps many MedTech founders awake at night. You need to iterate quickly to stay competitive, but regulatory compliance can't be an afterthought.
For medical device companies developing softPostsware-driven products, verification and validation (V&V) often feels like navigating a maze of regulatory requirements, testing protocols, and documentation demands. Yet V&
The medtech sector continues its rapid evolution, with digital innovation reshaping how medical devices are designed, manufactured, and deployed. As this transformation accelerates, staying informed about breakthrough technologies and industry
Why HIPAA Compliance is Non-Negotiable in Modern HealthcareThe healthcare technology landscape has fundamentally shifted. Today's medical device companies aren't just building hardware, they're creating comprehensive digital ecosystems that collect, process,
The Critical Intersection of Security and Innovation in Medical Device Software DevelopmentIn today's rapidly evolving healthcare landscape, medical device software development has become increasingly complex, demanding expertise that spans cybersecurity,