Quality assurance in medical 3D printing

Ensure the production of safe and effective 3D printed medical devices with our specialized consulting service at QasE3D. With our years of expertise in the field, we offer a meticulous review and analysis of your entire process, from medical imaging to postprocessing, with a sharp focus on quality management and risk awareness.

What We Offer

Our consulting service provides a detailed examination/audit of every stage of your medical 3D printing workflow. We assess key components such as imaging processing, design, print preparation, material handling, work environment, 3D printing, postprocessing and testing (verification/validation). Our goal is to identify potential areas for improvement, optimization, and risk mitigation, ensuring that your processes meet the highest standards of safety, effectiveness, and compliance.

Certificate of Excellence

For organizations that demonstrate exceptional adherence to quality and compliance standards, we proudly offer the Medical 3D Additive Manufacturing Certificate. This prestigious certificate is awarded when there are no major non-conformities found during (or demonstrably addressed after) our audit process, symbolizing excellence in producing safe and effective medical devices through 3D printing.

Why Choose Us

  • Expertise: QasE3D contracts seasoned professionals with extensive experience in medical 3D printing and quality management.
  • Patient-matched devices: Producing custom-made or patient-matched devices poses extra challenges in the interpretation of regulations and standards, with which we have ample experience.
  • Focus on Safety and Effectiveness: Just like the regulator, we prioritize safety and effectiveness in the production of medical devices. Our consulting services help you navigate the complexities of 3D printing to facilitate regulatory compliance.

Get Started Today

Ready to enhance the safety and effectiveness of your medical device production through 3D printing? Contact us today to schedule a consultation and take the first step towards achieving excellence.