Blog - Medical Device

What Is ISO 13485 Certification — and Why Should You Care?

Jen — September 22, 2015

ISO (International Organization of Standards) 13485 is a rigorous quality-management system and regulatory standard pertaining to the design and manufacturing of medical devices, ranging from life-saving medical equipment, such as artificial hearts or dialysis machines, to diagnostic tools, treatment devices, and hospital beds. All regulated medical equipment must meet specific standards to be sold internationally. …Read More

Start-Ups: Launching a New Medical Device Company? Here’s Where to Turn for Help

Anuva — May 5, 2015

Need Help Launching Your Biotechnology? Congratulations, you’ve created an innovative and revolutionary medical device. Believe it or not, that is the easy part. Now you have to create a business to take your product to market! Where can start-ups go to find help? One overlooked resource is the biotechnology center. Biotechnology centers were developed to …Read More

Are You Ready To Make Your Manufacturing, Post-Manufacturing & Support Pledge for Your Wearable Device?

Anuva — October 2, 2014

This is part 12 of our series, “The Future of Medical Technology: Wearable Devices.” Read Part 11 Here. It has been said “begin with the end in mind.”  This very much applies to New Product Implementations (NPI). Decisions and promises made early in any product-development process can greatly affect manufacturing and post-manufacturing support and costs. …Read More

Does Your Wearable Device Really Need a Smartphone Application?

Anuva — September 25, 2014

This is part 11 of our series, “The Future of Medical Technology: Wearable Devices.” Read Part 10 here. “There’s an app for that” is a ubiquitous statement nowadays. Does the wearable device that you are developing need a smartphone application? For the majority of wearable devices, the answer is yes. But some do not need …Read More

FAQs on Connecting a Wearable Device to the Cloud

Anuva — September 18, 2014

This is part 10 of our series, “The Future of Medical Technology: Wearable Devices.” Read Part 9 Here. When designing a wearable device, you might want to seriously consider connecting to a cloud service. Why? What exactly is the cloud? What benefits does the service provide? This article will answer those questions. The “cloud” is …Read More