I believe what bothers you at this point is the thought of the electronic equipment used in health centers. The accuracy of the medical device can determine whether the condition is correctly diagnosed and, therefore, provide appropriate treatment. The accuracy of the surgery or whether it provides the expected prognosis. The life of the person you love depends on these vivid factors, which will definitely make you dizzy. But don't worry, because all medical electronics must comply with considerable safety and quality standards.

To ensure that medical devices meet their critical system performance requirements, the International Electrotechnical Commission (IEC), International Standards Organization (ISO), US Food and Drug Administration (FDA), Federal Communications Commission (FCC), and other agencies issue medical device regulations and standards Companies that build and supply medical equipment must comply with these regulations and standards.
In terms of medical electronics design and development, the most widely used textbook has been for more than 14 years! why?

To a large extent, these standards are geopolitical. Each country has its own governing body and standards. Having said that, adherence to standards such as IEC and ISO covers all countries. Think of it this way, the fact that medical devices are so different and used in many different fields. This means that specific regulations will be made for specific equipment, depending on how and where it is used. Due to this changing nature of regulations, creating a complete list is almost impossible. Electronic innovation in medical technology has been accelerating, and the list was outdated before it appeared.

However, there are some key regulations you should be aware of when providing medical devices and equipment to your organization.

ISO 13485 Medical Devices: Quality Management System (QMS)-Standards for Regulatory Purposes
It defines specific requirements for the medical device industry regarding the entire sample space of the QMS. ISO 13485 is designed for organizations engaged in the design, production, installation and maintenance of medical equipment. It also enables audits by internal and external parties, such as certification bodies.

A medical device is a product, more precisely an instrument, machine, implant or in vitro reagent to assist in the diagnosis, prevention and treatment of disease.