Thomas Regulatory

CE marking for a medical device/equipment or IVD confirms that the device complies with regulatory requirements for entry into European countries. One of the most important standards for medical devices/equipment supplied in the European Economic Area is the CE marking (EEA). CE marking is a certification mark that indicates a product complies with European Union (EU) directives and regulations. In the case of medical devices, CE marking indicates compliance with the EU Medical Device Regulation (MDR) or the EU In Vitro Diagnostic Regulation (IVDR), depending on the type of device. The mark serves as proof that the device complies with all relevant safety, health, and environmental protection requirements, as well as any other applicable regulations. Only products that meet EU specifications and require the use of CE marking are subject to the requirement. Several EU regulations apply to some products at the same time. Before applying the CE marking to your product, make sure it compli...

FDA 510k Consultant assist you in navigating the entire Class I, Class II, and Class III device approval process by thoroughly understanding the device and identifying any potential hazard. Qualified and experienced technical experts ensure 510k clearance promptly. A 510(k) is a premarket submission to the FDA that demonstrates that the device to be marketed is as safe and effective as a legally marketed device (section 513(i)(1)(A) FD&C Act). A 510(k) is another name for a Premarket Notification because it refers to Section 510(k) of the Federal Food, Drug, and Cosmetic Act. That is why the terms 510(k) and Premarket Notification are frequently used identically. 510k Clearance, Submission, and Premarket Approval from the FDA Thomas Regulatory Resolutions is a leading medical device consultant who assists clients with the FDA 510k Clearance process and the registration of SBUs (Small Business Units), if applicable. Take out the product testing requirements, create the dossier, r...