Quality

Precision at
every step

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Quality Assurance

Our dedicated team of Quality Specialists ensures that all internal processes are conducted to our standard of excellence every day. Our digital Quality Management System facilitates the flow while safeguarding data integrity. They welcome Regulatory Authorities, Notified Bodies, Certification Agencies and Customers for audits.

Quality Control

Present at key steps of the manufacturing process, our QC experts monitor the quality and safety of our products. Trained by the leaders of the Analytical Chemistry industry, they have access to the latest equipment to provide the most accurate characterization of the product.

Regulatory Affairs

In the highly-regulated Medical Devices industry we are available to support our customer’s access to the market. We can prepare submission documentation and provide apostille upon request.

CAM Bioceramics understands the need for constant high quality. We have a track record in demonstrating our ability to provide calcium phosphates and related services that consistently meet customer needs and the regulatory requirements applicable to medical devices and related services.

Quality

From raw materials to finished product, with the highest quality

Our approach of using in-house production of the raw materials allows us to control the output to the highest possible degree. All of the in-process and final controls you would expect are available:

  • XRD, FTIR and titration measurements on chemical composition

  • Trace element quantification

  • Laser diffraction, density measurements and SEM imaging for particle characterization

  • S-BET for the characterization of the particle surface

    Our Quality Control guarantee that we comply with applicable standards (ISO, ASTM, USP and Ph. Eur), and also ensures batch-to-batch consistency.

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Industry of Analytical Chemistry Equipment

CAM invests in the latest equipment from the leaders of the Industry of Analytical Chemistry equipment. They support us in the qualification and validation, ensuring precision, accuracy, repeatability and robustness of all Quality Control measurements

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Compliance

The Quality Control lab complies to our general ISO 13485:2016 certificate and to GMP. Where applicable, the measurement methods comply to their related specific standard (such as ISO13320 for laser diffraction). Depending on requested specifications, global compliance to leading industry standards can be claimed, including compliance to ASTM F1185, ISO13779-6 for Hydroxyapatite and ASTM F1088 and ISO 13175-3 for Beta-TCP.

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Innovation

We love challenges and we welcome customer requests that push us to innovate and improve. We have experience in developing inhouse methods when no standards are available. We regularly investigate new techniques and methods to stay at the forefront of our domain.