EN ISO 10993-18 ( CHEMICAL CHARACTERIZATION OF MEDICAL DEVICE ) Chemical characterization is a crucial step in evaluating the biocompatibility of a medical device. It is done to identify and characterize the chemical constituents (extractable and leachable) which could disclose biological risks to patients and medical practitioners. Extractables are substances that can be…
[A] Non-Active Medical Device Labelling Information on the EU MDR Medical Device Labelling Requirements Name or trade name of the device. Necessary details for a user to identify the device, the contents of the packaging, and the intended purpose of the device. The name, registered trade name or registered trademark, and the address of its…
Premarket Notification Vs Premarket Approval [ 510k Vs PMA ] Class II medical devices require a 510k submission (premarket notification), while Class III medical devices require a PMA (premarket approval), but what is the difference in the process between the two? A PMA is a more detailed document than a 510k. PMA is used to…
Medical Device Submission Types in US FDA There are mainly 2 types of submission for medical devices in the FDA based on the classification. The classifications are based on intended use and indications, a risk-based classification. The medical device is classified into classe I, II and III in the FDA. Class I devices have…