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Quality

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 standard ISO 13485:2016. 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 Expert Services. (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 spirometers and accessories conform to the following standards:

  • Industry Recommendations - ATS 1994, ERS 1993, ATS/ERS 2005,
  • Quality System Regulations - European Medical Device Directive - MDD 93/42/EEC, ISO 13485:2016, and FDA QSR
  • Fulfill Standards – EN/IEC60601-1, EN/IEC 60601-1-2, EN/IEC 60601-1-6, EN/IEC 60601-1-9, EN/IEC 62304, EN/IEC 62366, EN ISO 14971 and EN ISO 26728.

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.

Certificates

EC Declaration of Conformity

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Certificate of Conformity

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RoHS Declaration of Conformity

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Quality System Certificate ISO 13485

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