At BioMDg, we prioritize rigorous pre-clinical and clinical testing as a foundational step in bringing your biologic or medical device to market. Our team conducts a comprehensive analysis to determine which consensus standards and FDA guidance documents are applicable to your product. This thorough understanding ensures that your development process aligns with regulatory expectations and best practices, paving the way for smoother approval and market entry.
Choosing the right animal model is crucial for validating your product’s safety and effectiveness. We assess various factors to determine the optimal and cost-effective animal model for your testing, ensuring that it provides reliable data without unnecessary expense. Additionally, we conduct risk analyses, including Failure Modes and Effects Analysis (FMEA), to evaluate packaging, sterilization, and biocompatibility. This proactive approach minimizes potential risks and enhances product reliability.
Maximizing Product Safety and Effectiveness Through Testing
Bench testing is another critical component of the development process. Our experts work with you to define bench testing requirements tailored to your product, ensuring that all necessary evaluations are conducted to demonstrate safety and performance. By aligning testing protocols with industry standards, we help you gather robust data that supports your regulatory submissions. With our support, you can confidently move forward in your development journey.
Ready to optimize your testing strategy? Get in touch to learn more about our comprehensive testing services and how we can support your pre-clinical and clinical efforts.
Tailored Bench Testing Requirements for Your Product
- Determine which consensus standards/FDA guidance documents may apply to product
- Determine the optimal/cost effective animal model to use (when applicable)
- Packaging/sterilization/biocompatibility Risk analysis (FMEA)
- Determine bench testing requirements