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 Diagnostic Consumables
What tests must clear before IVD consumables ship, how to write defensible release specs under ISO 13485 Clause 8.2.6, and the gaps that cause lot holds at scale.
Read ArticleMulti-Site CM Redundancy for Sterile Device OEMs
Single-site sterile packaging vendors create real supply chain risk. Learn what OEMs should demand from a contract manufacturer's redundancy architecture before the next disruption.
Read ArticleISO 14644 Cleanroom Class Selection for Device Assembly
Learn how to select the right ISO 14644 cleanroom class for medical device assembly — covering particle count thresholds, ISO 13485:2016 Clause 6.4 obligations under FDA's QMSR, sterility pathway logic, and common over- and under-engineering mistakes.
Read ArticleASTM D4169 Distribution Simulation for Medical Device Packaging
A technical guide to ASTM D4169 distribution simulation for medical device packaging validation—cycle selection, D4169-23e1 changes, and 510(k) documentation.
Read ArticleWhat the FDA’s QMSR Means for Medical Device OEMs and Manufacturing Partners
As FDA’s QMSR takes effect in February 2026, quality systems are evaluated differently. What OEMs and their partners should understand now.
Read ArticleASTM D4169 Schedule E: Random Vibration Testing
Understand ASTM D4169 Schedule E random vibration testing used to simulate vehicle-induced distribution hazards.
Read ArticleASTM D4169 Schedule I: Low Pressure (Vacuum) Testing
Learn how ASTM D4169 Schedule I evaluates package performance under low-pressure distribution environments.
Read ArticleASTM D4169 Schedule J: Concentrated Impact Testing
Learn how ASTM D4169 Schedule J evaluates concentrated impacts from handling equipment during distribution testing.
Read ArticleASTM D4169 Schedule F | Fixed Vibration Testing
Learn how ASTM D4169 Schedule F evaluates fixed vibration, what data it produces, and how to interpret results for packaging validation.
Read ArticleASTM D4169 Schedule C Compression Test
Understand Schedule C compression testing, typical failure modes, and how results inform distribution risk decisions.
Read ArticleASTM D4169 Schedule A | Manual Handling Test Interpretation
A technical guide to interpreting ASTM D4169 Schedule A manual handling test data for medical device packaging.
Read ArticleChoosing the Right Distribution Cycle for Packages
Learn how the distribution cycle impacts ASTM D4169 compliance and prevents costly errors in medical device shipping.
Read Article