Building Self Sampling Into a Clinical Trial

Self sampling is a protocol decision, not a kit decision. What to settle in the protocol, with the laboratory and in the instructions before you source a collection kit.

Learn More

What Audit Support From Your Kit Manufacturer Should Actually Look Like

When your regulatory lead audits your contract manufacturer, the job is not to pass. It is to produce evidence fast enough that your timeline does not slip. What they should be able to hand over, how fast, and what real audit support looks like.

Learn More

You Cannot Validate a Process You Have Not Developed

Validation confirms that a defined process is reproducible. It cannot create the definition. What development has to produce first, and how to tell you are validating too early.

Learn More

AQL, Sampling Plans, and the 100% Inspection Myth

What AQL actually means, how a sampling plan gets chosen, why claims of 100 percent final inspection usually do not hold up, and the six questions to ask a kit supplier.

Learn More

What FDA’s QMSR Means for At-Home Test Kit Companies

QMSR took effect February 2, 2026 and incorporates ISO 13485:2016 by reference into 21 CFR Part 820. What changed, what did not, what it means when you outsource kit assembly, and the seven questions to put to your manufacturer at the next review.

Learn More