Blog - Engineering

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

Mastering Project Management: 6 Takeaways from Anuva’s Newest Team Member

Erin — July 28, 2015

  As an associate project manager intern at Anuva – and a University of North Carolina, Chapel Hill, undergrad pursuing a Bachelor’s degree in Biomedical Engineering – I have learned an incredible amount in the past six months on the job. Far more than I could have gained in the classroom. Six project-management takeaways from …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

What Should Your Wearable Wear? Choosing Materials for Medical Device Enclosure

Anuva — September 4, 2014

This is part 8 of our series, “The Future of Medical Technology: Wearable Devices.” Read Part 7 Here. Material selection may be one of the most difficult decisions to make about your wearable device design. There are a large amount of basic plastics and metals to choose from. But when you consider additives, alloys, and blends, …Read More