MEDICAL DEVICES TESTING

Supporting medical device innovation through preclinical efficacy, safety and regulatory testing trusted by the life sciences sector worldwide.

Why Choose Pharmidex for Medical Devices Testing

  • GLP-compliant testing & reporting



  • In vivo and in vitro models tailored for device evaluation


  • Integrated PK/PD, biocompatibility and toxicity assessments


  • Expertise in CNS, oncology, respiratory and rare disease models


  • In vivo services are conducted in compliance with the highest international standards of care, including AAALAC accreditation

Regulatory & IND/IDE Support

Our team supports your regulatory strategy with high-quality data packages for:


  • IDE/IND-enabling studies


  • Risk analysis and preclinical validation


  • Global submission readiness

Combination Products & Drug-Device Interactions

We specialize in pharmacokinetics of combination products, including antibody-coated stents, depot injections and implantable release systems.


  • Drug release kinetics


  • BBB penetration assessment (for CNS-targeted devices)


  • Device-biological interaction profiling

Therapeutic Areas of Focus

  • Neurology (CNS devices, neurostimulation)




  • Rare diseases and niche indications

Our Medical Devices Testing Capabilities

Pharmacokinetics & Drug Release Profiling


For combination products, we assess drug elution, systemic exposure, and local tissue distribution using advanced analytical techniques.


  • DMPK studies for drug-eluting devices


  • Tissue-specific exposure and penetration


  • In vivo models in rodents (wild-type, immunodeficient, Tg32)

In Vivo  Efficacy & Safety


  • Custom small animal models for CNS, oncology, respiratory applications


  • Implantation site response, tissue integration, and biofunctionality


  • Longitudinal studies with imaging and behavioral readouts

In Vitro & Biocompatibility Testing


  • Cell viability & cytotoxicity assays (MTT, LDH, etc.)


  • Hemocompatibility & irritation studies


  • Material leachables and extractables

Bioanalytical Services


  • Quantitative analysis of biomarkers, cytokines, and APIs


  • LC-MS/MS, ELISA, and qPCR platforms


  • GLP-compliant documentation for regulatory submissions