Medical Devices

SYNLAB Pharma provides services for the biological evaluation of medical devices; all in accordance with ISO 10993. Our assay portfolio includes all relevant test models, either performed in-house or by our qualified collaboration partners. Testing for device registration and for the routine monitoring of production processes can be established. Clients are assisted in the decision process, finding the right strategy. Biocompatibility testing is performed in accordance with GMP, GLP and ISO 17025.

In this context, SYNLAB Pharma can offer routine analysis, method validation and the optimisation of test systems for medical devices. We deliver data of outstanding quality in customised formats while adhering to client timelines. This is proven by long-term relationships with customers worldwide, fulfilling  their expectations and requirements. SYNLAB Phrama can contribute to your success; working with you in partnership to help minimise the biological risks associated with medical devices.

Our Services:

  • Chemical characterization of materials (ISO 10993-18)
  • Genotoxicity (ISO 10993-3)
  • Haemacompatibility (ISO 10993-4)
  • Cytotoxicity (ISO 10993-5)
  • Implantation (ISO 10993-6)
  • Sensitisation (ISO 10993-10)
  • Determination of Endotoxins (ISO 10993-11)
  • Biodegradation (ISO 10993-9/ -13/ -14/ -15)
  • Irritation (ISO 10993-10)
  • Validated methods with different read-outs (e.g. XTT, Resazurin)
  • According to ISO-10993-5 and ISO-10993-12
  • Definition of testing strategies
  • Qualitysystems: GMP, GLP, ISO 17025 
     
  • Validated Kinetic turbidometric LAL test
  • According to USP <85> and USP <161>
  • Qualitysystems: GMP. GLP. ISO 17025
     

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