Extreme quality requirements for medical equipment
13 November 2020
Implantica specializes in innovative medical implants that simplify the treatment of several different medical conditions and improve patients' quality of life. For several years now, we have been helping them to manufacture advanced details for medical devices.
Prior to the production of all the details for the new implant RefluxStop, Implantica needed a partner with extensive experience in medical technology production. They were looking for a supplier who could meet the extreme requirements for documentation and traceability in the production of this type of product. Our carefully developed and very reliable quality assurance system as well as our efficient handling of technical documentation meant that the choice of supplier fell on us. The fact that we have extensive experience of medical technology production was also an important factor in the decision.
During the production of the new instrument, quality rounds were conducted where we validated all processes to meet customer requirements and live up to the extremely high safety and quality requirements. After approved production of prototypes, we are now the complete supplier of the instrument. We work with the highest traceability at all levels and follow all requirements for ISO 13485 after quality audits with customers. The product is packed with us in the workshop and delivered directly to the customer's warehouse ready for transport to hospitals.