Contract Pharma Solutions

Contract Pharma Solutions sets a new milestone with ISO 13485:2016

Contract Pharma Solutions sets a new milestone with ISO 13485:2016

Contract Pharma Solution started the year 2020 by marking an important milestone in its corporate history. We achieved to improve ourselves and to be recognised applying ISO 13485:2016 standard for Medical Devices. It is a very notable addition to the currently applied Good Manufacturing Practices (GMP) and Quality Management System’s (QMS) standards. ISO 13485:2016 Medical Devices permits us to increase the range of products for our clients with assured quality.

Client ordering a service to manufacture a medical device with Contract Pharma Solutions is guaranteed to have:

      • Products manufactured under established and constantly improved QMS
      • Properly documented processes and records
      • Management team which oversees effectiveness of QMS
      • Competent Personnel overseeing production according to device requirements
      • Risk based approach to quality when:
        • purchasing components
        • designing the product
        • measuring and validating equipment
        • and producing a device.
      • Quality checks before the delivery
      • Implementation of corrective actions in case of incidents