ISO 13485 Standard is a well-described standard to analyze the quality of medical devices and equipment. ISO 13485 Certification in Philippines | Short Audit and Reports | certificate in record time | Simple-Transparent | Contact:firstname.lastname@example.org. Call@ +6531591803.
The uses of ISO 13485 Certification for medical devices?
- As a medical device manufacturer, even if you not have the ISO 13485 certification, you have to comply with the applicable regulatory requirements to market your products. Compliance with regulatory Classes requirements is given equal importance in ISO 13485, with the latest version putting additional emphasis on this factor.
- The Food and Drug Administration (FDA) is a federal agency of the United States of America – responsible for safeguarding and maintaining public health through the regulation and supervision of medical devices and other products. The Center for Devices and Radiological Health (CDRH) is the authority for regulating and approving medical devices under the domain of the FDA.
- In 1976, the Federal Food, Drug and Cosmetic Act were revised. TheISO 13485 Certification Provider for Medical Device section was also amended, instituting three regulatory classes for medical devices. The three classes are based on the extent of control required to guarantee that the devices are safe to use and effective for their intended functions.
Significance of classes - medical device manufacturers and suppliers
- ISO 13485 Certification for Medical Devicehelps you to build a Quality Management System with the necessary considerations for the (above-mentioned) regulatory requirements. FDA’s CDRH, has three different medical device classes, and keeps strict control over the medical device market in the United States.
- Devices that are the least harmful (e.g., elastic bandages, mercury thermometers) do not require protocols to validate their safety and effectiveness. In the Classes Devices whose designs are already established as fit for purpose and safe for use undergo a simple notification process that usually does not require clinical trials, just an expression of equivalence with a previously approved and marketed device.
- Devices that are critical for life are categorized in Class III and undergo a detailed process of approval under which clinical trials are done. The results of clinical trials are kept confidential. Thus, the FDA has reduced the possibility of defective and life-threatening devices coming to market. It is important for the well-being of the people that devices are regulated. State authorities can make control over devices effectively by this way.