Quality Services

KTS logo 2 300px by 217px with shadow and textThe quality aspects of the device directives are addressed by compliance to ISO 13485. Kershaw Technology Services has extensive experience in development and implementation of processes the divers range of standards, which govern medical devices. Several examples of the standards employed are given below.

  • ISO 13485 Quality Management for Medical Devices,
  • ISO 14791 Medical devices – Application of risk management to medical devices,
  • ISO 10993, Biological evaluation of medical devices
  • ISO 2859 Sampling procedures for inspection by attributes

The company also provides tailored procedures and training in the ISO 13485 and its supporting standards examples of which include;

  • Risk management Procedures
  • Process development and validation
  • Design and development
  • Control of manufacture to ensure that the product functionality is maintained