Blog
May 25, 2026
A toxicology strategy is a structured plan that connects your safety data to your regulatory pathway. It does more than confirm that a product won't harm patients — it tells reviewers how you evaluated risk, why your evidence is sufficient, and what that means for market clearance or approval. Without it, even a clean set of tox studies can stall a submission.
May 18, 2026
The team had a problem. Their medical device needed a biocompatibility explanation. Not necessarily a huge testing program. Not necessarily a stack of lab reports. But they needed a clear reason why the device was biologically safe. So someone wrote: “The device is made from medical-grade materials and is therefore biocompatible.” That sentence looked harmless.
May 11, 2026
Theme: Biocompatibility Audience: Medical device founders, quality teams, regulatory teams, importers, and anyone trying to understand what FDA may ask in a 510(k) Estimated read time: 7–8 minutes Medical Devices: Irrigation […]
May 4, 2026
A device that passes material inspection can still fail ISO 10993 biocompatibility testing — and understanding why the difference between a delay and a disaster is. Kandih Regulatory Insights · The team thought this would be easy. The material was "medical grade." The supplier had used it in healthcare for years. The device seemed simple enough, and the regulatory plan looked clean.
