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Expertise
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Engineering

Process V&V

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.

We support your validation project on different sages:

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

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

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

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.

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.

 

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

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