Quality Management System
Since 2012 Medspray has implemented a quality management system complying with ISO 13485, QSR 820 and Part 11. We have investigated relevance to GMP and concluded following :
- No specific US-GMP requirements relevant for Medspray (QSR covers all)
- No specific EU-GMP relevant for Medspray (ISO13485 covers all)
- No specific GLP/GMP for the Aerosol Laboratory
For Manufacturing, including manufacturing of SNUs, we decided to work according to Annex 1 of the EU-GMP regulation.
ISO 13485 Certificate
Download a copy of our ISO 13485 Certificate
The Management of Medspray is fully committed to the conformance of their aerosol and spray products to customer and regulatory requirements. Management of Medspray implements and maintains a quality system covering the design, manufacture, supply and customer feedback of Medspray aerosol and spray devices. Medspray: makes the quality of the Medspray aerosol and spray devices first priority; communicates to employees and suppliers the importance of meeting customer and regulatory requirements; establishes and maintains the Quality Management System of Medspray to ensure its effectiveness and compliance with ISO 13485; ensures adequate availability of resources to meet or exceed customer and regulatory requirements.
Medspray is ISO 13485 certified on development and manufacture of our products and we work according to FDA-QSR and GMP. At the end of the development our medical devices are CE-marked under Annex II of the Medical Device Directive. For devices intended for clinical trials we will issue a statement according to Annex VIII of the Medical Device Directive. Even in pharmaceutical programs involving clinical work, CE marking speeds up projects, since CE-marked devices enter clinical work without submission of (the device part of) dossiers, eliminating at least one possible cause of delay and risk of failure.