It is the policy of Medisize, to produce and sell high quality products and meet all relevant national and international regulatory requirements, quality system requirements and product requirements. The Medisize QMS provides a foundation for a healthy organization that is able to effectively and efficiently develop, produce and deliver the products and services that are required by the customer. To make this possible the organization provides the necessary means and tools. Medisize will actively communicate, propagate, support and continually improve the effectiveness of the Medisize QMS. A range of quality and general objectives is defined, measured and evaluated on all levels of the organization.
Medisize quality systems
Operations based on regulatory requirements:
- 93/42/EEC on Medical Devices
- FDA 21CFR Part 820 Quality System regulations
Certified global processes according to:
- ISO 13485:2016 (Download as PDF)
- ISO 9001:2015 (Download as PDF)