Quality
Dedicated to quality
The Medspray management reviews the quality management system, including the quality policy and quality objectives, at planned intervals to ensure its continuing suitability, adequacy, and effectiveness. This review includes assessing opportunities for improvement including the need for changes to the quality management system.
ISO 13485:201
Since 2010, Medspray has been certified for having an ISO 13485 compliant quality management system for the design, development, and manufacture of medical devices. In addition, Medspray complies with the relevant requirements of Title 21 CFR Part 820 (Quality System Regulations for Medical Devices) and Title 21 CFR Part 11 (Electronic Records and Electronic Signatures).
Download a copy of our ISO 13485 Certificate
Quality Policy
The Medspray management is fully committed to the conformance of its aerosol and spray devices and products to customer and regulatory requirements. Medspray implements and maintains a quality system covering the design, manufacturing, supply and customer feedback of Medspray aerosol and spray devices.
The management of Medspray:
- prioritizes the quality of the Medspray aerosol and spray devices
- communicates the importance of meeting customer and regulatory requirements to employees and suppliers
- establishes and maintains our Quality Management System to ensure compliance with EN ISO 13485 and
Title 21 CFR Part 820 - ensures adequate availability of resources to meet customer and regulatory requirements