Class III Medical Device A series of medical devices are available on the market, and are classified into different sub-categories like Class I, Class II, and Class III devices. As per “the Food and Drug Administration,” the medical devices are classified into these three categories. Out of which, you will get to know about Class…
Free access to ISO 13485 standard, other medical device and personal protection equipment standards To sustain the campaigns taking care of the impact of COVID-19, the International Organization for Standardization (ISO) has made a few of its standards supporting the assessment of medical devices as well as personal protection equipments used in healthcare setups easily…
ISO 13485 certification is a requirement for medical device companies that wish to market their products in Europe and around the world. What is iso 13485 certification ? The ISO 13485 standard was published by the International Standards Organization to give medical device firms with needs for developing and maintaining quality systems. While medical device…
Responsible Authorities in Korea FDA Medical devices in South Korea are managed by Medical Device Act and controlled by The Ministry of Food & Drug Safety (MFDS) or formerly Korea FDA. Under the jurisdiction of the Act, requirements for medical devices are provided in numerous various titles of guidelines. Below is a list of the…
FDA 510k: Everything you need to know about preparing a premarket submission for medical devices A 501k is a device classification that allows manufacturers to sell their products without first obtaining approval from the FDA, but only if they meet specific criteria. That is, an FDA 510k submission is the technical documentation required by the…