medical devices - Hattrick's Blog

IEC 62304 Clause 5 in practice: building a development process that survives FDA review

Clause 6 of IEC 62304 is where most teams get hurt. We covered that last month — the maintenance traps, the frozen risk files, the patch backlogs that become audit findings.

testing

Software Verification and Validation for Medical Devices: What Teams Need to Know

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&

medical devices

Essential Medical Device & MedTech Conferences to Attend in 2026

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

design

UX for Regulated Medical Device Software: Risk, Safety & User-Centered Design

User experience (UX) in medical device software isn't just about great visuals or smooth navigation, it's about maximizing patient safety, minimizing risk, and ensuring regulatory compliance. A confusing alarm system

medical devices

What Makes a Software Company Qualified for IEC 62304 Projects?

When you're developing regulated medical device software, choosing the right development partner can determine whether your product reaches market on time or gets stuck in regulatory limbo. IEC 62304 compliance

cybersecurity

Medical Device Software Development: A Comprehensive Guide to Security and Compliance

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,

ai

AI in Medical Device Software: What Health Innovators Should Know

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

medical devices

Medical Device Cybersecurity: What MedTech Leaders Need to Know

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

medical devices

10 Accelerators and Incubators Revolutionizing Medical Device Innovation

The medical device industry thrives on innovation, with startups driving advancements that redefine healthcare delivery and improve patient outcomes. However, the medical device industry has a high barrier to entry

medical devices

Top Medical Device Conferences To Attend in 2025

The exponential growth of digital technologies in healthcare has dramatically transformed the medical device industries, creating an environment of unprecedented innovation and rapid development. This accelerated pace of technological advancement

medical devices

World Heart Health Day: How Technology is Revolutionizing Cardiac Care

This blog post explores how unhealthy lifestyle choices contribute to heart disease, the importance of early intervention, and the transformative role technology plays in modern cardiac care.

medical devices

Navigating the Regulatory Landscape: The application of risk management to medical devices according to ISO 14971

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

medical devices

HIPAA Compliance and Data Security in the World of Medical Devices

This era can easily be defined by the rapid technological advancements we’ve been seeing. Healthcare is an industry that’s undergoing an evolution. Medical devices, ranging from wearable health

medical devices

IEC 62304 latest version: which are the medical device software standards?

The landscape of healthcare technology is ever-changing, it’s an industry where innovation and patient care intersect, hence why the development and deployment of medical device software is of extreme

health

Software as a medical device (SaMD): meaning, benefits, challenges and more

In recent years, the use of software in the medical field has become increasingly common. One particular area of software that has gained attention is software as a medical device

medical devices

A run-through of the security and privacy issues with healthcare information technology

There seems to be a lot of confusion in the healthcare world between security and privacy. These two terms are related but respond to different issues. In broad terms security

medical devices

The 2022 State of Digital Therapeutics and FDA Regulations with 6 examples

The treatment of some physical and mental health related conditions is going digital and has evolved into its own field. These are therapies that use digital technology to not only

connected health

Remote Patient Monitoring Definition (RPM): What you should know

Remote patient monitoring (RPM) is changing the healthcare system. It’s making the lives of patients and physicians a lot easier. Why? You may ask. This is because traditionally in

health

A quick overview of the process for getting a Medical Device approved by the FDA

If your company is planning to bring a new medical device to market, FDA approval is one of the most important steps you can take. The U.S. Food and