Since July 2006 Glide Pharma has been audited and certified by SGS as meeting the requirements of BS EN ISO 13485: 2003 Medical Devices – Quality management systems – Requirements for regulatory purposes. The scope of the certification is: Control of the Design and Manufacture of Drug Delivery Devices.
The Glide SDI® consists of two separately packaged components; a re-usable actuator and a single use, sterile, disposable cassette containing the medicinal substance. Within the European Union the Glide SDI° is regulated by two directives:
- The Medical Devices Directive 93/42/EEC (as amended by Directive 2007/47/EC) regulates the actuator which is classified as a medical device. The actuator will be CE marked when placed on the market.
- The Medicines for Human Use Directive 2001/83/EC regulates the cassette which is classified as a medicinal substance.
