FDA Compliance
The European Commission’s latest Joint Actions on Compliance of Products (JACOP) project offers a useful starting point for understanding why products can still fail environmental compliance checks even when manufacturers have established compliance programs.
Published in June…
Ask a premarket team where corrective and preventive action (CAPA) sits on the priority list, and it usually lands below design controls, risk management, and the submission itself. The reasoning is easy to follow. Nothing has shipped, so there are no complaints to investigate, no returned…
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…
A CEO doesn’t need to read every AI law to understand why regulation matters. It shows up in subtler ways: a sales team using a chatbot with client data, a hiring manager testing an AI screening tool, a board member asking whether the company has an AI policy. AI governance has moved from 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…