Classification of medical devices – ISO 13485 Certification
The medical device manufacturer makes the best medical device that serves as an apparatus, an implementation device, the machine, appliance, implant, and reagent for in vitro use, software, material or other similar articles. The medical devices are produced by the manufacturers that are intended to be used alone or in combination, for human beings, for one or more of the specific medical purposes such as,
• Diagnosis, prevention, monitoring, treatment or alleviation of disease
• Diagnosis, monitoring, treatment, alleviation of or compensation for an injury
• Investigation, replacement, modification, or support of the anatomy or of a physiological process
• Supporting or sustaining life
• Control of conception
• Disinfection of medical devices
The medical devices are classified based on the classes as class I, class II and class III. The risk factor for all these classes is segregated as low risk, moderate risk and high risk. As the class number increases the risk also increases. At the same time, the level of the regulatory control also increases. With Global Quality services (GQS), you can get a better understanding regarding the classes for the medical devices. We are the leading consulting firm for offering ISO certifications for different classes of medical devices.
The class – I type of medical are at the least risk factor and they don’t need a high level of regulatory control. Almost, 780 families of medical devices are under this class I type. If your device falls under the generic category of class I, the manufacturers must register their product with the concerned administration departments. The class I medical devices requires only the general control. When compared with class I, the class II and class III needs special control in addition to the general control and the important fact is that the manufacturers who produce the class III medical devices must get the premarket approval. The medical devices can also be classified into active, non-active, in-vitro diagnostic and active implantable medical device. As discussed about the general and the special controls for the medical devices, the medical device manufacturer must know about the basics and methods of the general and special control for the medical devices. The general control methods include registration, listing of the medical device, adulteration, and misbranding. Some of the special control types include special labelling requirement, performance standards, and the PMS.
The Global Quality Services (GQS) is the leading consulting firm for the offering the ISO certifications for the concerned medical device manufacturer. We always ensure that the medical device manufacturer must follow all the proper guidelines throughout the entire process of making the medical devices. Global quality services will do proper auditing and appropriate methods to make sure that the devices are manufactured by following all the rules and guidelines as per the norms.
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