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Certification & Commitment to Quality for our Cameras for Medical & Life Sciences

Your trust is our top priority. That is why we commit ourselves to the highest standards of quality. With its certification under ISO 13485:2016, Basler has proven its quality management system (QMS) for the development, production, sales and service of digital cameras for applications in medicine, medical technology and life sciences. As a manufacturer of medical equipment with a camera*, you benefit from this quality standard. Because, with our certification, we already take some of the work off your hands and facilitate the auditing of your products.

*Our cameras are image processing components. They are not a medical product in the sense of the medical product law.

The Benefits of our ISO 13485:2016 Certification for You

  • Uniform quality standards
  • Separate production with specific Camera Test Tools (CTT)
  • Product continuity ensured through design freeze for the camera hardware and firmware
  • Product Change Notification (PCN) in the event of product changes
  • Traceability of components
  • Low auditing effort for the customer
  • Facilitation of compliance with guidelines for the manufacture of medical products

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Product Continuity Ensured by Design Freeze

Product Continuity Ensured by Design Freeze

Cameras for Medical & Life Sciences are distinguished by their reliability. We guarantee this by means of a design freeze, which means that the hardware and firmware of our Basler MED ace will not be altered after product production begins. If there are any changes, we can inform you upon request with a Product Change Notification (PCN).

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Tested Quality – From the Beginning to the End and Back

Tested Quality – From the Beginning to the End and Back

Cameras for applications in the Medical & Life Sciences field are subject to the highest quality requirements. How do we fulfill these? Through our separate production of our Basler MED ace cameras in a cleanroom, our strict quality tests and the traceability of important components.

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You Have Questions, We Have the Answers!

How do you benefit from our QMS according to ISO 13485:2016? How do we assure the quality and reliability of our products in the Medical & Life Sciences field? No matter what drives your business, our sales team will provide assistance!

Contact our sales team

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