About 3Dresyns® certifications

3Dresyns® operates within a framework of quality management, traceability and regulatory awareness appropriate for the development and supply of advanced photopolymer systems for additive manufacturing.

Certifications and compliance statements related to 3Dresyns activities must be interpreted within the context of materials development, supply and technical support, rather than as blanket certifications of all possible applications or end uses.

Scope and meaning of certifications

Certifications associated with 3Dresyns relate to specific aspects of company operations, such as quality management systems, internal procedures or defined activities, depending on the certification scheme.

They do not imply automatic certification, approval or regulatory clearance of all products, applications or end-use devices manufactured using 3Dresyns materials.

Certifications versus application validation

In additive manufacturing, especially for regulated applications, there is an important distinction between company-level certifications and application-level validation.

While certifications may demonstrate that certain processes or systems are in place at the organizational level, validation of printed parts or devices remains dependent on the specific material version, processing workflow and intended use.

Relationship with medical and dental applications

For medical, dental and other regulated applications, the use of 3Dresyns materials must be supported by appropriate application-specific validation performed by the device manufacturer or user.

Certifications held by 3Dresyns do not replace the need for workflow validation, regulatory compliance or conformity assessment required by applicable regulations.

Transparency and responsible communication

3Dresyns is committed to transparent and responsible communication regarding certifications and compliance. Information is provided to clarify the scope and limitations of certifications, avoiding misinterpretation or overextension beyond their intended meaning.

This approach supports informed decision-making and proper alignment with regulatory and quality requirements.

Governing principle

Certifications associated with 3Dresyns describe defined aspects of organizational processes or quality systems. They do not constitute blanket approval of materials, applications or end-use devices, whose performance and compliance depend on system configuration and validated workflows.

This principle ensures accurate and responsible interpretation of certifications within the context of system-based photopolymer additive manufacturing.