Phthalate plasticizers provide flexibility in medical devices yet these endocrine disruptors accumulate in patients through chronic exposure - particularly concerning for neonatal and pediatric populations where developmental impacts prove most severe. Phthalate analysis by GC-MS detects 13 regulated compounds following global restrictions on these endocrine disruptors, with extraction techniques liberating phthalates from polymer matrices for accurate quantification. The methodology addresses REACH, CPSIA, and medical device regulations restricting phthalate use particularly in pediatric applications, with sensitive detection ensuring compliance with increasingly stringent limits. Critical for PVC-based devices where alternative plasticizers require validation demonstrating acceptable toxicological profiles, pediatric devices with stringent phthalate limits protecting vulnerable populations from developmental harm, and demonstrating compliance with expanding global restrictions targeting additional phthalate compounds. Quality control applications include raw material verification ensuring suppliers provide phthalate-free or compliant materials, monitoring plasticizer migration from packaging where phthalates transfer from PVC packaging into contained devices, and validation testing alternative plasticizers confirming phthalate-free formulations. For medical devices with extended patient contact particularly neonatal intensive care equipment, phthalate testing validates that cumulative exposure remains within safe limits, alternative plasticizers replacing restricted phthalates don't introduce equally concerning compounds, and processing modifications reduce phthalate content in legacy products. The testing accommodates various phthalate types from traditional DEHP through replacement phthalates now facing restrictions, quantifies both free phthalates and bound plasticizers that migrate during use, and supports risk assessment calculating patient exposure from device contact duration and phthalate levels. Manufacturing investigations use phthalate testing identifying contamination sources when screening detects unexpected levels, validating cleaning procedures remove phthalate residues from equipment, and demonstrating formulation changes successfully eliminate restricted phthalates while maintaining material performance.