The 5 Necessary Steps for Medical Device Commercialization
There are five critical steps that are necessary for medical device commercialization. Have you considered each of these?
How FDA and EU MDR Regulations Differ for Medical Device Companies
The EU MDR vs FDA regulations both have a few differences that medical device manufacturers should be aware of. Here’s a quick rundown:
FDA 510(k) and Pathways to Market for New Medical Devices
Developing a new medical device? Determining your FDA pathway to market early can help to smooth your way. Here are three possible routes:
Medical Device Regulation
Are you equipped to meet medical device regulatory needs today, and adjust for the changes of tomorrow? FDA medical device regulation can be quite complex — and for good reason. There are many different laws, rules, and best practices that may affect your cloud-connected medical device today, and in the future. EU medical device regulation […]
12 Sleep Technology Medical Devices Revolutionizing Sleep
Are you getting enough sleep? If you’re like the majority of the population, the answer is: probably not. Not getting enough sleep can impact your physical and mental health, causing things like workplace injuries, decreased memory, increased irritability, and even symptoms of depression. In fact, sleep deprivation is linked to 7 out of the 15 […]
Somnera™ gets FDA Clearance with the Help of Galen Data
Somnera (formerly Fresca Medical) is a medical device company with a focus on sleep devices. The company developed an innovative low-flow positive airway pressure system for patients with obstructive sleep apnea. Working with a tight timeline, Somnera enlisted the help of Galen Data to achieve device-to-cloud connectivity in a fraction of the time (had they [&h
9 Medical Device Startups that Investors Love in 2021
Venture capital investments are the lifeblood of many successful technology startups, and medical device companies are no different. In fact, medical device companies often require more early-stage capital due to the capital-intensive nature of manufacturing a device and the clinical and regulatory requirements. With the much-needed capital and expertise these
California SB-327: The Security of Connected Devices
What California’s iOT Security Law Means for Medical Devices In September 2018, California’s governor signed Senate Bill 327, the Security of Connected Devices, into law, which went into effect on January 1, 2020. Its purpose was to extend already existing privacy laws to connected devices and the information they collect, store and transmit. Unlike the
Tips for a Successful Quality Audit
by Steve Ford, OMEDtech The medical device industry is a highly-regulated and constantly-evolving landscape, and, as a result of global and national regulations, there is an increased focus on auditing. It is critical to be prepared for third-party audits, as they are responsible for confirming your quality management system (QMS) compliance. Preventative audit
NIH and NSF Grants for Medical Device Startups
From concept to commercialization, the cost of launching a startup can seem overwhelmingly high. This reality is especially true for medical device startups, which require more capital than most prior to going to market. Thankfully, organizations like the National Institutes of Health (NIH) and the National Science Foundation (NSF) can help ease the initial cap
