Regulatory updates, validation guides, and microbiology testing insights for medical device QA and operations teams. New posts published monthly.
May 2026 · Boulder BioLabs
The 2024 revision tightened bioburden monitoring, annual revalidation, adoption studies, and MPQ language. What it means for your EO validation package.
Read article →May 2026 · Boulder BioLabs
Current FDA endotoxin guidance status, where it's moving on rFC and CSF-contact limits, and what to do now.
Read article →May 2026 · Boulder BioLabs
A March 2026 peer-reviewed CD residuals toxicity framework gives device manufacturers a citeable reference for the first time. Here's how it changes the CD validation conversation.
Read article →May 2026 · Boulder BioLabs
A practical bioburden trending discipline for QA managers running quarterly monitoring — action limits, investigation triggers, and the most common drift causes.
Read article →May 2026 · Boulder BioLabs
Five common 483-finding patterns around method suitability (bacteriostasis/fungistasis), and the QMS practices that prevent each one.
Read article →May 2026 · Boulder BioLabs
Most EO-sterilized devices are aerated longer than they need to be because of logistics, not process. Co-locating residuals testing with the sterilizer recovers 36-48 hours per cycle.
Read article →Downloadable PDFs for QA leads and manufacturing teams. Email-gated; we send the file and never spam you.
Free PDF · 4 pages
Eight questions to answer before your sterility testing program starts. For QA leads preparing for an ISO 11135 EO validation.
Get the PDF →Free PDF · 3 pages
How to sample, label, and ship EO residuals samples for ISO 10993-7 compliance. Or just hand them across the campus.
Get the PDF →Free PDF · 4 pages
Where chlorine dioxide fits, how the validation differs from EO, and what the March 2026 peer-reviewed framework means for your program.
Get the PDF →Our published guides cover the regulatory framework. For a validation program scoped to your device, sterilization method, and timeline, talk to our team directly.
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