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 ...

Company is among the first in China's drug-device combination products sector to obtain this certification, delivering superior solutions to global clientsZero non-conformities demonstrates company's ...

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 ...

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 SEooC model provides an ideal approach for developing high-quality software elements out of context. Using the methods defined in ISO 26262, these elements offer a specific functionality and meet ...

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 ...

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 ...

ISO (International Organization for Standardization) and IEC (International Electrotechnical Commission) have just published a new guide to help standards writers address safety aspects in medical ...

Automotive functional safety System-on-Chips (SoCs) for Advanced Driver Assistance Systems (ADAS) contain several complex Intellectual Property (IP) cores. The IP cores are developed as a Safety ...