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.
IoT devices for telehealth devices
Imaging Devices & Equipment
Medical monitoring systems
Radiation therapy or radiotherapy
Patient tracking & monitoring systems
Devices that enhance patient-hospital interactions
Biometric integration for a digital patient recording
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.
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.
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.
Directives of the European Union that restricts the use of specific hazardous materials in electrical and electronic devices.