Medikro Quality Management System
 High product quality is an important objective for Medikro. For Medikro high product quality means not only product reliability and accuracy but also user-friendly devices.
Medikro Quality management system assures high quality from early developing phase to the final product quality assurance and customer feedback system. Medikro takes customer requirements and wishes into consideration when developing new products.
Medikro's quality management system is certified according to the European Union Medical Device Directive 93/42/EEC and according to standards ISO 9001:2000 and ISO 13485:2003. Medikro's quality management system meets essential requirements for other marketing areas like FDA Quality System Regulations for the USA.
Our quality system is annually audited by our notified body VTT Industrial Systems. (Notified Body no 0537 under council directive 93/42/EEC)
Our products are designed to meet applicable safety requirements of IEC/EN 60601-1 series standards.
Conformance to Standards
Medikro SpiroStar DX and Medikro SpiroStar USB devices conform to the following standards:
- Industry Recommendations - ATS 1994
- Quality System Regulations - FDA QSR, ISO 13485:2003 and ISO 9001:2000
- Product Testing Regulations - EN60601/IEC601 series: 60601-1, 60601-1-1, 60601-1-2, 60601-1-4 and European Medical Device Directive - MDD 93/42/EEC
Product Quality Assurance
The quality and reliability of final products is Medikro's primary interest. Final Testing is made for every spirometer unit after manufacturing by using Pulmonary Waveform Generator. Also Disposable Flow Transducers are 100% tested and verified.
Product Certification
Medikro's spirometer products are CE marked (CE 0537) and meet applicable CE requirements in Europe and also applicable medical approvals in other countries.
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