Blog - ISO 13485

3 Benchmarks for Picking a Medical Contract Manufacturer

Jen — November 10, 2015

You create the plans and ideas for your medical equipment with care, ensuring every step is carefully followed and all quality measures are satisfied. Once you reach the stage of developing the product, it only makes sense to choose your manufacturer with the same care. This may seem like a daunting task, but Anuva, the …Read More

Why is using an ISO 9001, ISO 13485, and AS 9100 Certified Company Important?

Jen — October 20, 2015

The Benefits of Using an ISO 9001 vs. ISO 13485 vs. AS 9100 Certified Company ISO 9001 is a Quality Management System recognized worldwide, and is the basis for ISO 13485 and AS 9100. While these three QMSs have similar goals, the corporations utilizing them differ. Choosing a medical device development firm with a recognized …Read More

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

5 Pitfalls When 3D Printing

Anuva — March 24, 2015

              3D printing is one of the most rapidly growing technologies today. In many situations, it is unbelievably useful and efficient. It can drastically reduce product-prototyping costs and timelines. It allows parts to be modified and replaced with ease. It provides insurance before sending parts to large-scale production. However, …Read More

Does My App Need to Be FDA Regulated?

Anuva — October 30, 2014

This is part 15 of our series, “The Future of Medical Technology: Wearable Devices.” Read part 14 here. In today’s ever-changing world of technology, things have gotten more complicated with the use of apps for wearable devices. There are apps on the iPhone and Android platforms for almost everything, from tracking your run to telling …Read More