demcon-macawi-short-time-to-market
uniqueness of the MRM

compliance to standards.

To ensure respiratory ventilators are safe and perform reliably, regulatory authorities require proof of compliance with applicable legislation and product standards. For many developers, this certification process can feel like a major hurdle.  

relieving the hurdle of regulatory submissions.

The Macawi Respiratory Module (MRM) is designed for seamless integration into your ventilator system. It is developed in accordance with all relevant state-of-the-art product standards for intensive care unit equipment and transport ventilators.

To support your certification process, we provide pre-compliance documentation that can directly be used in your regulatory submissions. Our team is available to offer technical support, helping you gather the necessary information and shorten your time to market.

Team Macawi
Category
Standard
Pre-compliance information
Electrical safety IEC 60601-1Pre-compliance information is available for basis safety and essential performance of medical electrical (ME) equipment.
ICU ventilators IEC 80601-2-12Pre-compliance information is available for transport ventilators.
EMC IEC 60601-1-2The module is tested for pre-compliance during development. Still your ventilator should be tested as a complete product since EMC effects are related to the complete product.
Transport / Emergency EN 1789Pre-compliance information available for use in road ambulance.
Transport / Emergency EN 13718-1Compliance information available for air ambulances.
Transport / Emergency IEC 6060-1-12Pre-compliance information available for emergency ventilators.
Transport / Emergency ISO 80601-2-84Pre-compliance information available for emergency ventilators.
Oxygen monitoring IEC 80601-2-55The ventilators need to comply with some specific requirements of this standard. Pre-compliance for the Module is available.
Biocompatibility ISO 18562The module is tested for pre-compliance according to the ISO 18562 2017 series. Material information about parts in the gas path can be provides to support your files.
Oxygen compatibility ISO 15001The module holds a high pressure oxygen inlet. The high pressure parts of the module meet ISO 15001.
Shock & vibration (up to RTCA)Shock & vibration tests have been performed for pre-compliance of the design with the RTCA criteria for shock & vibration.
Quality management ISO 13485The module is developed by Macawi according to the processes of Macawi. Macawi is ISO 13485 certified.
Software development IEC 62304The firmware of the module is developed according to the requirements of IEC 6203034 class C software so that the documentation supports the categories of all use cases.
discover more about

the Macawi Respiratory Module.

every breath matters.

Discover how the Macawi Respiratory Module can help you bring life-saving ventilation closer to reality. Request your evaluation kit and take the next step with confidence. Our team is here to support you every breath of the way.