Quality certificates

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's Quality Management System ensures high quality from the early development phase to final product quality assurance and customer feedback. Medikro takes customer requirements and wishes into consideration when developing new products.

Medikro's quality management system is certified according to the European Union regulation (EU) 2017/745 and according to the standard ISO 13485:2016. Medikro's quality management system meets essential requirements of FDA Quality System Regulations (21 CFR PART 820), Canada Medical Device Regulations (SOR/98-282) and Australian Therapeutic Goods (Medical Devices) Regulations 2002.

Our quality system is annually audited by our Notified Body (NB no 0537).

Our products are designed to meet the 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 - according to the European Union regulation (EU) 2017/745, ISO 13485:2016, and FDA QSR (21 CFR PART 820), Canada Medical Device Regulations (SOR/98-282) and Australian Therapeutic Goods (Medical Devices) Regulations 2002.
• Applied Standards –
  • ISO 13485:2016/A11:2021, Medical devices, QMS
  • EN ISO 10993-1:2020, Biological evaluation of medical devices
  • EN ISO 10993-5:2009, Tests for in vitro cytotoxicity
  • EN ISO 10993-10:2021, Tests for irritation and skin sensitisation
  • EN ISO 14971:2019/A11:2021, Risk management
  • EN ISO 15223-1:2021, Symbols
  • EN ISO 20417:2021, Information to be supplied by the manufacturer
  • EN ISO 23747:2015, Anesthetic and respiratory equipment
  • EN ISO 26782:2009, Anesthetic and respiratory equipment
  • EN 60601-1:2006/A1:2013/A2:2021/A13:2024, General safety requirements for medical products
  • EN 60601-1-2:2014/A1:2021, Electromagnetic compatibility
  • EN 60601-1-6:2010/A1:2015/A2:2021, Usability
  • EN 60601-1-9:2007/A1:2013, Environmentally Designed
  • EN 62304:2006/A1:2015, Software life-cycle processes
  • EN 62366-1:2015/A1:2020, Usability

Product Quality Assurance

The quality and reliability of final products are Medikro's primary interests. Final Testing is made for every spirometer unit after manufacturing by using the Pulmonary Waveform Generator. Also, Disposable Flow Transducers are 100% tested and verified.

You can download the following quality certificates.

• Medikro, MDR, EU Declaration of Conformity, Class I (Sent on request.) 
• Medikro, Manufacturer's Declaration, Class IIa
• Medikro, MDR, EU Declaration of Conformity, Calibration Syringe
• Medikro RoHS Declaration of Conformity
• Medikro ISO 13485
• Medikro DQS, MDSAP Certificate
• MDR, EU Declaration of Conformity, M9488 & M9492 (Sent on request.)
• MDR, EU Declaration of Conformity, M9256 (Sent on request.)
• MDR, EU Declaration of Conformity, M9831 (Sent on request.)
• MDR, EU Declaration of Conformity, M9497 (Sent on request.)
• EU Certificate, MDR
• MDR, EU Declaration of Conformity, M9242 (Sent on request.)

Service Equipment Certification

The following certificates pertain to the production equipment used in our service process for Calibration Syringes and Spirometers.

Code	Equipment Type	Calibration Certificate
ME-002	Furness Micromanometer	FSL03106
ME-008	PWG 6 Pulmonary Waveform Generator	M-25L184
ME-011	Mitutoya bore gauge	K022-P24446
ME-012	Mitutoya height gauge 192-614	K022-P24443
ME-023	Vaisala PTU301 #2 Vaisala PTU300 (500-1100) digital barometer	K008-J02206
ME-028	Vaisala PTU301 #2 Vaisala PTU300 (500-1100) digital barometer	K008-H03006
ME-057	Vaisala HM41 humidity and temperature meter	K008-H07278