ISO 13485: Comprehensive Overview of the Medical Device Quality Management Standard
ISO 13485 is the internationally recognized standard for quality management systems (QMS) in the medical device industry. It specifies the…
Standards
Using SysML and MBSE for Better Compliance in Medical Device Development: How MBSE Tools Can Ensure ISO 13485 Compliance
The development of medical devices requires rigorous compliance with safety and regulatory standards such as ISO 13485, which outlines requirements…
Automated Testing for ASPICE-Compliant Software Development: Leveraging Automation in ASPICE Verification and Validation
ASPICE (Automotive SPICE) is a process assessment model widely used in the automotive industry to evaluate the maturity and quality…
Feature-Based Modeling in Automotive Engineering Using ASPICE: Streamlining Development with Feature Models
As the automotive industry evolves, the development of vehicles is increasingly driven by software and the need to manage a…
Bridging the Gap Between ASPICE and ISO 26262: A Practical Approach to Compliance Using Architecture Models
In the development of safety-critical automotive systems, compliance with both ASPICE (Automotive SPICE) and ISO 26262 is essential. However, these…