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