Standards
Medical device companies selling into multiple countries don’t answer to one global regulator. They navigate a patchwork of national requirements that two organizations are trying to align in very different ways.
The International Medical Device Regulators Forum (IMDRF) and the…
Product compliance is moving beyond certificates and restricted-substance checks. PFAS restrictions, digital product passports, artificial intelligence, supply-chain transparency, and sustainability increasingly require manufacturers to connect regulatory knowledge with reliable product,…
In the electrotechnology sector, we know one thing for certain: Trust can’t be imposed; it must be built. Standardization enables us to build it every day. As the world grapples with climate, digital, and societal challenges, manufacturers, electricity producers, grid operators, conformity…
The recent multistate outbreak of cyclosporiasis is a powerful reminder that food quality involves more than appearance, consistency, and shelf life. It requires an integrated approach to food safety, supplier control, traceability, risk management, and continuous improvement.
By…
Quality teams throughout the food manufacturing industry face increasingly difficult obstacles and risks while keeping our food safe. A team can discover a positive Listeria result on a slicer component inside a ready-to-eat production zone after earlier environmental monitoring signals in the…
As this article is being written, the (final draft) FDIS ISO 9001:2026 global vote has concluded, and we should soon see the new published requirements.
If published as drafted, which is widely expected, one of the most significant changes is an increased emphasis on demonstrating…