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Biocompatibility of medical devices - tests, analyses and validation

SYNLAB pharma provides services for the biological evaluation of medical devices; 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 offers routine analysis, method validation and the optimisation of test systems for medical devices.

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Fellbach wird neuer Laborstandort
Nach zweijähriger Planungs- und Umbauphase entstand in Fellbach das neue Labor der SYNLAB Analytics & Services Germany GmbH.
Aug 10, 2018 Continue
Determination of the Impurity N-Nitroso dimethyl amine (NDMA) in Drug Substances with GC-MS

Due to contamination of a drug substance with the potential mutagenic substance N-Nitroso dimethyl amine (NDMA) a massive recall campaign was initiated for the related drug products. SYNLAB Pharma offers a GC-MS test for testing the absence of NDMA in drug substances and drug products.

Please contact our experts.

Jul 13, 2018 | Pharma Continue
New Services in Regulatory Compliance for Biologics

With immediate effect, SYNLAB Pharma provides a broad support in the field of Regulatory Compliance of Biologics development. With this new services we support specifically start-ups, small to medium sized biotech companies, which require professional consultancy and project execution in regulatory project design.

For further questions, please contact:

pharma@synlab.com

Jun 18, 2018 | Pharma Continue
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