ISO 13485 is a QMS standard that comes from the internationally recognized and accepted ISO 9000 quality management standard series. If you’re looking to establish a device’s effectiveness, then this might be the system for you all about ISO 13485 Certification. For details Call us +91 9962590571
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 Radio logical 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. The 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.
Regulatory classes for medical devices to ISO 13485 Certification
The classification procedure and market approval processes are fully explained in the 21 CFR Part 860 (Code of Federal Regulations for Medical Device Classification Procedures). The FDA, in the United States, permits devices to access the market through two regulated paths. The easiest and most widely used is the 510(k) process (which is titled after the CFR section).
When a supplier can prove that it’s newly Introduced device is Similar to a former officially supplied medical device, it can access the market with the permission of the FDA as the defined controls required in this process are met. The 510(k) process doesn’t involve the high level of testing that clinical trials require.
The other path to the marketplace is the Premarket Approval (PMA) process, which requires approval by the FDA. Following are the classes of medical devices: