…the NHS and are ready for compliance when UDI becomes mandatory under the new MDR? 1. Grasp first-mover advantage Immediately start to make the move to introduce UDI. Although the…
…the NHS and are ready for compliance when UDI becomes mandatory under the new MDR? 1. Grasp first-mover advantage Immediately start to make the move to introduce UDI. Although the…
…in commercial distribution or is reintroducing into commercial distribution, but that is about to be significantly changed or modified in design, components, method of manufacture, or intended use. The following…
…in commercial distribution or is reintroducing into commercial distribution, but that is about to be significantly changed or modified in design, components, method of manufacture, or intended use. The following…
Medtronic has issued a voluntary recall of all unused units of its StrataMR adjustable valves and shunts. The company notified customers on February 22, and the recall could affect 2622…
Medtronic has issued a voluntary recall of all unused units of its StrataMR adjustable valves and shunts. The company notified customers on February 22, and the recall could affect 2622…
…to replace the TPP, but such negotiations are a lengthy process. For example, the United States entered bilateral trade negotiations with South Korea in early 2006, but the final free…
…to replace the TPP, but such negotiations are a lengthy process. For example, the United States entered bilateral trade negotiations with South Korea in early 2006, but the final free…
…to come. References Recommendation for the Entropy Sources Used for Random Bit Generation. (January 27, 2016). Retrieved from http://csrc.nist.gov/publications/drafts/800-90/draft-sp800-90b.pdf FDA. Unique Device Identification. Retrieved from https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/ Resource Chatwin, L. (September…
…to come. References Recommendation for the Entropy Sources Used for Random Bit Generation. (January 27, 2016). Retrieved from http://csrc.nist.gov/publications/drafts/800-90/draft-sp800-90b.pdf FDA. Unique Device Identification. Retrieved from https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/ Resource Chatwin, L. (September…
…FBI alerts by emailing Cywatch@ic.fbi.gov alerts. This resource will keep companies updated on breaking news and other FBI updates in cybersecurity. The agency also encourages device companies to have a…
…FBI alerts by emailing Cywatch@ic.fbi.gov alerts. This resource will keep companies updated on breaking news and other FBI updates in cybersecurity. The agency also encourages device companies to have a…
…a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (February 2017). Inspections, Compliance, Enforcement, and Criminal Investigations. Denttio, Inc. Accessed March 31, 2017. Retrieved…
…a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (February 2017). Inspections, Compliance, Enforcement, and Criminal Investigations. Denttio, Inc. Accessed March 31, 2017. Retrieved…
…products is strongly complementary to our cornerstone Lotus valve platform, and this compelling combination of technologies will allow us to provide interventional cardiologists and cardiac surgeons with multiple TAVI offerings…
…products is strongly complementary to our cornerstone Lotus valve platform, and this compelling combination of technologies will allow us to provide interventional cardiologists and cardiac surgeons with multiple TAVI offerings…
…Europe, Asia, and other markets in North and South America. Meridian Medical Technologies, a Pfizer company, is Mylan’s manufacturing partner (Mylan is the distributor). The recall has occurred as a…
…Europe, Asia, and other markets in North and South America. Meridian Medical Technologies, a Pfizer company, is Mylan’s manufacturing partner (Mylan is the distributor). The recall has occurred as a…
…the new products are both better on quality and pricing), there is an opportunity to potentially disrupt and capture competitors’ market share immediately upon entering the market. Let’s walk through…
…the new products are both better on quality and pricing), there is an opportunity to potentially disrupt and capture competitors’ market share immediately upon entering the market. Let’s walk through…
