When people think of robotics, they often think about warehouses or manufacturing lines, where robots automate multiple processes. But robotics has the potential to reshape the way healthcare is delivered in a variety of applications and locales. While we’re a long way from a robot replacing a physician, there are many opportunities to provide automation […]
FDA removed 10% of medtech establishments from its registration database: Here’s why
David Lennarz, Registrar Corp. The U.S. FDA has removed 2,546 medical device establishments from its active registration database. As of Feb. 19, the FDA database contained 24,578 registered establishments, compared to 27,124 registered establishments on Feb. 2. So why did FDA remove the registrations? Get the full story on our sister site Medical Design & […]
Current Regulatory Landscape for EO Residue Levels in Medical Devices
One of many crucial steps a single-use medical device takes on its journey from concept to commercial product is sterilization. Ethylene oxide gas sterilization, in particular, is one of the most efficient and effective ways of deactivating bacteria and other potentially dangerous living microbes from medical devices; however, manufacturers must take care to control and […]
Upcoming changes to FDA electronic medical device reporting in 2018
Registrar Corp. Medical device manufacturers and importers are required to report “adverse events” to FDA when their device has caused or contributed to death or serious injury. An adverse event is when a device has a malfunction that could cause death or serious injury. Importers report this information to the manufacturer. The FDA has announced […]
3 Steps to Increase the Accuracy and Speed of Your Next Medical Device Recall
Recalls in the med-tech industry aren’t going away. In this white paper, you’ll find proven strategies to increase the efficiency of your recall strategy. These have been developed through our experience working with several of the largest med-tech companies in North America, who have told us that this method is “changing the way all recalls […]
FDA publishes final guidance for UDI direct marking requirements
David Lennarz, Registrar Corp. The U.S. Food and Drug Administration (FDA) requires devices intended to be reprocessed or devices intended to be used more than once by multiple patients to physically bear a permanent unique device identifier (UDI) marking that lasts the duration of the devices’ expected lifetime. This is known as UDI direct marking. […]
The Case for Real-World Evidence (RWE) in Medical Device Development
Medical Devices are used in the real world every day, so shouldn’t they be tested in the real world? You would think so. But the FDA hasn’t necessarily been of that mindset — until now. Per FDA regulations, testing has to be conducted under supervised clinical trials, which have pre-designed protocols. When most think of […]
New Study Reveals How Medical Device Companies Can Earn Trust and Drive Revenue Growth
To meet the needs of the triple aim and help improve operational and cost efficiencies, hospital executives are looking for manufacturers to move beyond products to become problem solvers. With this in mind, medtech companies can deliver end-to-end solutions hospitals need, an opportunity worth $44 billion in the U.S., to help them transform the way […]
MassDevice.com +5 | The top 5 medtech stories for October 20, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in […]
MassDevice.com +5 | The top 5 medtech stories for October 19, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in […]
MassDevice.com +5 | The top 5 medtech stories for October 18, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in […]
