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.
Impella 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.
Read ArticleQSR to QMSR: What the 2026 Transition Means
The QMSR took effect February 2, 2026, folding ISO 13485:2016 into 21 CFR Part 820. Here is what changed across sterilization, packaging, and assembly.
Read ArticleOur Packaging Lab Is Now ISO/IEC 17025 Accredited
LSO's in-house packaging test lab is now ISO/IEC 17025:2017 accredited. What that changes for seal strength, aging, and distribution data in FDA submissions.
Read ArticleBioburden Testing in Radiation Sterilization Validation
How pre-sterilization bioburden data drives ISO 11137-2 dose setting, how to design a sampling plan, and why a bioburden excursion can force revalidation.
Read ArticleWhat the Abiomed Impella Recalls Teach OEMs
The Abiomed Impella Class I recalls map cleanly onto specific ISO 13485 assembly gates. Here is the checklist OEMs can use to avoid the same recall vectors.
Read ArticleASTM D4169 Distribution Simulation for Packaging
How ASTM D4169 distribution simulation fits an ISO 11607 packaging validation program: cycle and Assurance Level selection, test sequence, and failure disposition.
Read ArticlePortfolio-Wide Warning Letter? Consolidate to One QMS
A portfolio-wide FDA warning letter is usually a QMS problem, not a product problem. Why OEMs consolidate finished-device assembly under one unified QMS.
Read ArticleSterile Barrier Material Selection Under ISO 11607-1
Tyvek, foil laminates, or coated paper? Learn how to choose sterile barrier materials under ISO 11607-1 based on sterilization method, peel force, MVTR, and biocompatibility.
Read ArticleISO 11607 Packaging Validation: The Complete Guide
How ISO 11607 Parts 1 and 2, ASTM F1980 aging, F88 seal testing, and D4169 distribution simulation build a packaging validation program that holds up in a 510(k).
Read ArticleConvenience Kit Recalls Land on the OEM. Here's Why.
FDA treats a sterilized convenience kit as one finished device. When it fails, the OEM owns the recall. How single-QMS assembly and sterilization prevents it.
Read ArticleReprocessing Validation Lessons From the Medline Recall
The FDA's most serious recall hit reprocessed catheters over residual particulate. Here's why reprocessing validation has to be device-specific science.
Read ArticleWhat the Namic Kit Recall Reveals About Assembly QMS
A defective purchased syringe pulled convenience kits across multiple assemblers. Here's where ISO 13485 purchasing and acceptance controls actually live.
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