Our Commitment to Safety and Quality
At Corporis Medical, our foremost priority is the safety and quality of our products. We are dedicated to providing the medical field with innovative solutions designed to reduce surgery time and minimize post-operative complications. This commitment to excellence is deeply ingrained in our company culture, and all employees receive extensive training to uphold the highest standards of product quality and safety. Since September 2020, Corporis Medical has been ISO 13485:2016 (PDF) certified, underscoring our dedication to maintaining superior quality and regulatory compliance in the development and manufacturing of medical devices.
Regulatory Compliance
Corporis Medical is fully compliant with the Medical Device Regulation (MDR), ensuring that all our products are CE marked and adhere to both national and international regulatory standards. Our adherence to MDR encompasses several critical aspects:
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Enhanced Safety and Performance Standards: Our products undergo rigorous evaluations to meet the stringent safety and performance criteria established by the MDR, including comprehensive pre-clinical and clinical assessments to ensure optimal performance.
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Robust Documentation and Traceability: We maintain comprehensive technical documentation for all our products as mandated by MDR. This includes detailed records of design, manufacturing processes, and post-market surveillance to validate compliance.
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Vigilant Post-Market Surveillance: In alignment with MDR guidelines, we will actively monitor our products post-market to swiftly identify and address any potential issues, thereby ensuring sustained safety and effectiveness.
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Employee Training and Awareness: Our team is extensively trained in MDR requirements and remains current with regulatory updates, ensuring that all employees are knowledgeable and aligned with the latest standards and practices.
By adhering to these MDR requirements, Corporis Medical not only ensures the highest quality of our products but also reaffirms our commitment to the safety and well-being of patients globally.
