Bridging the Gap to Clinical Success: Preclinical Testing for Medical Devices & Pharmaceuticals
On the path from laboratory research to clinical application, safety assessment is the pivotal metric for ensuring patient safety and regulatory compliance (e.g., TFDA, FDA, EMA). Weshin Inspection Tech integrates deep expertise in toxicology and molecular biology to provide preclinical evaluation services that adhere to international standards.
Biological Evaluation of Medical Devices: The ISO 10993 Framework
For medical devices, ISO 10993 is the universal language for biocompatibility. We provide tiered evaluation strategies based on the nature and duration of device contact:
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Core Classification Criteria:
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A - Limited Contact: Less than or equal to 24 hours.
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B - Prolonged Contact: Exceeding 24 hours but up to 30 days.
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C - Permanent Contact: Exceeding 30 days.
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Key Testing Items: Includes Cytotoxicity (ISO 10993-5), Sensitization and Irritation (ISO 10993-10/23), and Systemic Toxicity assessments.
Preclinical Safety Assessment for Pharmaceuticals
For pharmaceuticals, we follow GLP (Good Laboratory Practice) and ICH guidelines to conduct rigorous toxicological studies before human clinical trials:
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Pharmacological Studies: Verifying the drug's mechanism of action and efficacy.
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General Toxicology: Includes acute, sub-acute, and chronic toxicity tests to evaluate the Safety Margin of the drug candidate.
Why Choose Weshin Inspection Tech?
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Precision Molecular Diagnostics: Leveraging our technical strengths in Primer Design and DNA Sequencing, we can observe the impact of drugs or devices on cellular gene expression at the molecular level.
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One-Stop Regulatory Consultation: We assist clients with Study Design and data interpretation, accelerating the timeline for market registration.
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Customized Experimental Protocols: We provide tailored experimental strategies for specialized materials or complex pharmaceutical formulations to meet specific project requirements.
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