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,
The Revolutionary Impact of AI in Medical Device SoftwareThe healthcare landscape is experiencing an unprecedented transformation as artificial intelligence becomes deeply embedded in medical device software. From AI-powered diagnostic software
Why Cybersecurity Matters in Medical Device SoftwareAs healthcare technology rapidly advances, medical device cybersecurity has become a mission-critical priority for MedTech innovators and manufacturers. Connected devices—from wearable sensors to
The Significance of Breast Cancer Awareness MonthOctober marks Breast Cancer Awareness Month, which is a global campaign dedicated to raising awareness regarding one of the most common cancers affecting women
In the dynamic world of healthcare, innovation and patient well-being intertwine, which is why the development and deployment of medical devices demands a commitment to safety and efficacy. Ensuring the