Ottawa, Can., March 19, 2019 — Feenics Inc., an award-winning provider of the Access Control as a Service (ACaaS) Keep by Feenics™ cloud-hosted platform, has been certified as an International ...

What is ISO 13458? This is the easy part; ISO 13485 specifies requirements for a quality management system (QMS) where an organization needs to demonstrate its ability to provide medical device ...

Structural flaws are hiding in plain sight, and a shift is long overdue, writes Pujitha Gourabathini at Becton, Dickinson and ...

Design Inputs are the king of medical device product development. If a product in the market has issues, I bet the Design Inputs defined during product development were insufficient. Design Inputs are ...

A family of standards and guidelines for quality in the manufacturing and service industries. ISO 9000 defines the criteria for what should be measured. ISO 9001 covers design and development. ISO ...

In the functional safety world, once a system is developed, it remains protected as long as the system is in service. In contrast, the security world demands that software must continue to defend a ...

The modern automobile is a maze of interactive electromechanical systems. Many of them, such as brakes, steering, airbags, powertrain, and adaptive driver assistance systems, are critical to human ...

ISO stands for the International Standards Organisation, an independent body that encompasses a vast network of experts from different disciplines. Together, these experts pool their knowledge and ...

Medical device design and development is a process that helps to ensure devices that go to market are safe, effective, marketable, and profitable. The process is a blueprint of the phases needed to ...