News & Insights
Read the latest LSO medical device manufacturing, packaging, and sterilization insights featuring reliable resources and industry expertise you can count on. Industry updates, technical guides, company news, and practical insights on medical device manufacturing, packaging, sterilization, and supply chain strategy from LSO.
Lot Release Testing for IVD Consumables
How IVD consumable lot release works: release panels, criteria set during validation, 100% inspection vs sampling, and ISO 13485 Clause 8.2.6 records.
Read ArticleDiagnostics Consumable Manufacturing: Prototype to Scale
How IVD consumables move from prototype to commercial volume: cleanroom requirements, lot release, scale-up pitfalls, and ISO 13485:2016 mapping under the QMSR.
Read ArticleScaling Diagnostic Consumable Manufacturing
A practical guide to scaling IVD consumables: cleanroom class, process validation, lot release, supply chain, and the CM QMS-to-DHF interface.
Read ArticleQMSR Inspection Readiness: Mapping What Auditors Want
QSIT is retired and FDA now inspects under Compliance Program 7382.850. Here is how to map QMSR inspection readiness across your supply chain.
Read ArticleASTM F88 Peel Testing for Medical Packaging
How to set up ASTM F88 seal-strength testing — fixture configuration, grip speed, jaw breaks, slippage, and mapping peel force to ISO 11607-1 criteria.
Read ArticleQMSR Audit Prep: What Investigators Expect From Your CM
Under the QMSR, familiar QSR anchors now live as ISO 13485 clauses and more records are inspectable. What OEM quality teams should verify in their CM.
Read ArticleThe QMSR Era: What Changed for OEMs and Their CMs
The QMSR took effect February 2, 2026, folding ISO 13485:2016 into FDA's quality framework. What it means for OEM quality systems and CM oversight.
Read ArticleQualifying and Auditing a CM Under QMSR
A quality director's guide to qualifying and auditing a contract manufacturer under QMSR: ISO 13485 Clause 7.4 controls, pre-audit docs, and agreements.
Read ArticleQMSR Readiness: What Changes and What Auditors Want
The QMSR took effect February 2, 2026. Here's what changed under 21 CFR Part 820, where early 483s are clustering, and how to harden supplier quality systems.
Read ArticleCleanroom Assembly for Medical Devices: A Decision Guide
How to select an ISO 14644 class by device risk, design assembly and gowning flow, monitor under ISO 13485 Clause 6.4, and qualify a CM cleanroom.
Read ArticleScaling Microfluidic Cartridge Assembly to Volume
How IVD teams scale microfluidic cartridge assembly: bonding method selection, critical dimensions, cleanroom controls, and lot-release testing.
Read ArticleImpella Recalls: What OEMs Learn About Assembly Gates
The Abiomed Impella recalls show how cleanroom process gaps become public FDA events, and how defined assembly gates keep introducer leak defects off the market.
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