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7 Examples of Software as a Medical Device (SaMD)
Software as a medical device is a relatively new and revolutionary tool in healthcare. It can collect massive amounts of data much faster than traditional means and perform complex medical manipulations like diagnosing, clinical management, and suggesting treatments. If you’re interested in learning...
Prepare Your Manufacturing Business for a Recession
Although not officially announced yet, it seems likely that our economy will be going into a recession (2 consecutive quarters of negative GDP). For advanced manufacturing companies, this could mean reduced orders and revenue due to less products being purchased, so customers need less invetory. If ...
Why We Love Building SaMD: BloodHub
At The Refinery, we have designed and built a huge variety of software, applications, portals, websites, etc. for multiple industries and sectors. And sure, they have an impact on people's lives in one way or another. But designing and developing SaMD (software as a medical device) is different, and...
AI in Medical Devices May Transform Healthcare
The article When We Put AI in Medical Devices, Magic Starts to Happen recently came across my news feed. It’s hard not to see how much artificial intelligence is being leveraged all around us, though I was surprised to learn that more than 350 AI-based medical devices have already been approved by t...
Designing HIPAA Compliant Websites
A well-designed and user-friendly website is a necessity for any business or organization today. This includes hospitals, healthcare providers, and any other companies that deal with medical data and PHI (protected health information). Along with all the best practices for designing and developing a...
What are the 4 Types of System Integration
Many companies use multiple systems in their everyday business operations. One system might act as a CMS for ecommerce products, another might keep track of inventory. The problem that arises when using multiple systems is that the more systems that are being used, the less efficient and productive ...
What are the 4 Risk Categories of SaMDs?
There are many variables that go into identifying and classifying software as a medical device. It’s important to remember that SaMD is not software which supports the functions of medical hardware (that’s an SiMD). To determine if software qualifies as SaMD, two questions must be asked: Does the s...
The Big Stick - Thoughts from Our CEO
After reading this article titled Big Sticks, some key points really stuck with me because of my own experiences owning a business for almost 20 years. As with many small business owners, my role has transitioned as the team has grown from working full-time in the delivery of our services to primari...
What is Software as a Medical Device (SaMD)?
Technology has progressed faster over the past two decades compared to any other span of time in history. Today, even software can be considered a medical device and approved by the EU and FDA. What I am referring to is a SaMD. A SaMD (Software as a Medical Device) is defined as: “Software intended ...
5 Rules You Need to Know About HIPAA Compliance for Web Apps
Keeping medical data safe and secure is more crucial than ever these days, and this is why HIPAA compliance continues to become more stringent. Things continue to go digital and smartphone technology is used for almost everything (payment, sharing data, etc.), so it’s no surprise that both web and m...
Am I Responsible for HIPAA Compliance Even if I Don’t Store PHI?
If you’ve recently been to a doctor's office or hospital, you’ve signed a piece of paper regarding HIPAA (The Health Insurance Portability and Accountability Act). HIPAA compliance is the set of rules and regulations created to help protect PHI, or personal health information. These standards primar...