A Beginner’s Guide to Design Controls for Connected Medical Devices
What do you need to know about design controls for your connected medical devices? Our beginner’s guide breaks down the key components:
Why Medical Device Startups Need a QMS Early
As a medical device startup, when should you establish your QMS? We make the case for getting started ASAP...
What Healthcare Investors Look for in Medical Device Companies
Is your medical device company looking to attract healthcare investors? Here’s what they’re looking for before they invest:
The 5 Necessary Steps for Medical Device Commercialization
There are five critical steps that are necessary for medical device commercialization. Have you considered each of these?
Where is Digital Health Heading in a Post-Covid World?
Where is digital health heading in a post-covid world? Innovations are set to continue - here’s where we see the future of connected solutions:
How FDA and EU MDR Regulations Differ for Medical Device Companies
The EU MDR vs FDA regulations both have a few differences that medical device manufacturers should be aware of. Here’s a quick rundown:
What Is SaMD? A Quick Guide for Medical Device Startups and Investors
What is SaMD? Here’s why both medical device startups and investors should take a second look:
FDA 510(k) and Pathways to Market for New Medical Devices
Developing a new medical device? Determining your FDA pathway to market early can help to smooth your way. Here are three possible routes:
The Disadvantages of Technology in Healthcare
Technology permeates our lives more than ever, as technological advances continuously emerge. Every industry has been upended and transformed, including the health and medical industry. While any innovation may seem like progress, there are certainly both advantages and disadvantages of technology in healthcare. Surgeons today can perform feats that years ago
What a Colonial Pipeline Attack Teaches Us About Cybersecurity
The cyber attack on the Colonial Pipeline experienced heavy media coverage last month, and for good reason. The important pipeline system — largely used to carry gasoline and jet fuel throughout the southeastern USA — was hacked for a payout of 75 bitcoin, or roughly $5 million. And while that is certainly a large payment, […]
