We support you in qualifying, validating / verifying your additive manufacturing processes from feedstock qualification up to standard post-processing.

You profit directly from our validation experts and a milestone-based cost calculation.

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We support your validation project on different sages:

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1: Responding to your specific questions regarding qualification and validation of your additive manufacturing processes. We also advise on equipment selection.

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2: Developing and planning Qualification and V&V strategies and concepts according your requirements. Development of a validation master file and risk analysis (PFMEA).

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3: Establishing your process mapping, risk assessment, qualification and validation (IQ, OP, PQ, Verification), standard operation procedures and reports.​

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A regulated environment with the application of norms and standards such as ISO 13485:2016 for medical technology and ISO/ASTM 52900 for additive manufacturing provide guidance for machine qualification and validated processes.

We are inspired from our daily experiences to provide you with the best advices.

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Our experts turn these guidelines into a productive additive manufacturing line and support you with many years of experience in MedTech and 3D printing industries.​​​​​​​​​​​​​​​​​​​

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​Below: an example of an IQ, OQ, PQ and requalification print job with propriatary test samles used to controll the entire 3D printing process.