Medical Devices Blog
ISO 17025: Laboratory Quality Management System Requirements and Accreditation Guide
TLDR: ISO 17025:2017 is the international standard for the competence, impartiality, and consistent operation of testing and calibration laboratories. It
The Future of Quality Management: AI, Automation, and Regulatory Trends for 2026 and Beyond
TLDR: Quality management in life sciences is shifting from a documentation-heavy, reactive discipline to a data-driven, proactive function. AI is
Digital Transformation in Life Sciences Quality: Challenges, Risks, and Opportunities
TLDR: Digital transformation in life sciences quality is not a single technology decision. It is a sustained organizational shift from
Remote Audits in Life Sciences: Best Practices and Technology Requirements
TLDR: Remote audits have moved from a COVID-era workaround to a permanent fixture in life sciences quality programs. Regulators including
How to Handle Customer Complaints Under FDA and ISO Requirements
Every regulated company receives complaints. The ones that get into trouble with the FDA or their notified body are usually
How to Validate Computer Systems Under FDA’s CSA Guidance
For decades, pharmaceutical and medical device companies validated computer systems using a documentation-heavy approach rooted in traditional IQ/OQ/PQ protocols. For