Supporting Companies in Process Validation
We understand that process validation is a critical step in ensuring the quality, safety, and regulatory compliance of medical devices manufactured using 3D printing technologies. We support companies throughout the entire validation journey by offering expert guidance and hands-on assistance.
Our services include:
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Developing Validation Strategies: We help define tailored validation plans that align with regulatory requirements and specific production needs.
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Process Characterization: By thoroughly analyzing and documenting the additive manufacturing process parameters, we ensure repeatability and consistency.
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Qualification of Equipment and Materials: We assist in qualifying 3D printers, materials, and post-processing equipment to meet stringent quality standards.
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Execution of Validation Protocols: Our team conducts process performance and product quality validation tests, generating detailed reports and evidence needed for regulatory submissions.
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Continuous Monitoring and Improvement: We implement monitoring procedures and advise on process optimizations to maintain validated states throughout the product lifecycle.
By partnering with Swiss m4m Center, companies gain access to specialized knowledge and state-of-the-art facilities that help streamline their process validation efforts, reduce time to market, and ensure compliance with standards like ISO 13485 .
