Industries

Healthcare Industry

Paving the way to adapt Healthcare 4.0

Mefron's team focuses on quality, hygiene, precision, and standards in every step of manufacturing healthcare products because we are obliged to ensure medical safety and meet stringent hygiene requirements.

It is a challenge for healthcare institutions to adopt cutting-edge technologies and tap into new markets due to a fluid regulatory environment and skyrocketing R&D and manufacturing costs. This is where the role of Mefron comes in. Mefron focuses on the rising development of devices that connect patients and healthcare providers in the Healthcare 4.0 era. We enable all healthcare institutions to easily adapt to the latest Healthcare 4.0 standards by providing state-of-the-art technology at a reasonable price.

Healthcare 4.0

We Focus on

IoT devices for telehealth devices

Imaging Devices & Equipment

Ventilator electronics

Medical monitoring systems

Robotic surgery

Radiation therapy or radiotherapy

Patient tracking & monitoring systems

Devices that enhance patient-hospital interactions

Biometric integration for a digital patient recording

Standards we follow for Medical instrument manufacturing

1.

ISO 13485:2016

The specifications for a quality management system for medical devices are laid out in this standard. It encompasses every stage of the product lifecycle, from design to manufacturing, installation, and maintenance.

2.

IEC 60601

These standards cover the functionality and safety of medical electrical equipment. It covers matters like electrical safety, electromagnetic compatibility, software validation, and standards for the device's mechanical and electrical components. It also defines electromagnetic requirements (EMI and EMS) of medical PCBs.

3.

FDA regulations

The US Food and Drug Administration (FDA) have a set of laws that must be followed depending on the type of medical device being developed. The rules cover subjects, such as post-market monitoring, labeling, and manufacturing controls.

4.

RoHS

Directives of the European Union that restricts the use of specific hazardous materials in electrical and electronic devices.

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079-66111038