Finished Products Testing and Batch Release
Ensuring the safety, quality, and compliance of finished medical devices is paramount. Our consultancy offers specialized Finished Products Testing and Batch Release Services to help you verify that all products meet rigorous quality standards and regulatory requirements before reaching the market.
Our Finished Products Testing and Batch Release Services Include:
- Comprehensive Testing: We conduct thorough testing of finished products, including functional, performance, and safety tests, to ensure they meet specified criteria and regulatory standards.
- Batch Release Verification: Our team reviews and verifies each batch of products, ensuring that all quality and compliance requirements are met before release. This includes reviewing manufacturing records, test results, and compliance documentation.
- Regulatory Compliance: We ensure your finished products testing and batch release processes comply with all relevant industry standards and regulatory requirements, including ISO 13485, FDA, and EU MDR. Our experts stay updated on regulatory changes to ensure ongoing compliance.
- Documentation and Traceability: We provide detailed customized documentation for all testing and batch release activities, ensuring traceability and creating a clear audit trail. This includes test reports, Certificates of Conformance (CoC), and batch release records.
Why us?
With extensive experience in the medical device industry and deep expertise in quality assurance and regulatory compliance, our consultancy provides tailored solutions to meet your specific needs. We help you ensure that every product batch is thoroughly tested and compliant, ready for safe and effective use in the market.