Health Canada clarifies when medical device changes require licence amendments. Key insights for manufacturers on risk, software, and design changes.

FDA releases updated guidance on pyrogen and endotoxin testing. Key clarifications for medical device and pharma manufacturers.

The FDA has released its final guidance on Computer Software Assurance (CSA) for production and quality system software, introducing a risk-based, streamlined approach to validating software used in manufacturing and quality operations. The updated framework helps manufacturers reduce unnecessary documentation, focus validation efforts on functions that impact product quality and patient safety, and accelerate the adoption of automated and digital technologies while remaining fully compliant with FDA requirements.