Medical Devices

Are you curious about how to complete your FDA 510(K) submission this year, or if you’re even required to do so? Here’s what you’ll need to know. Before a medical device can be legally sold on the open market, it must meet specific regulatory requirements. The requirements needed for different medical devices strongly depend on their […]

Five miles from Global Strategic Solutions, LLC, here in the Silicon Valley area of California, is where Theranos was located. I rode my Cervélo carbon fiber road bike by the building many Saturdays as I was exercising. It was my time to think creatively, plan enthusiastically, and reflect thoughtfully. Little did I know that building would be

Unsuccessful Startups Are All The Same. They Are Uniquely Unsuccessful. The need. The solution. The market. Can you speak to these in one minute? It can be that easy initially. You may have heard the buzz surrounding medical device technology. It’s a growing market. Artificial intelligence, gig speed internet, and many other high-tech advancements have opened

How to Write an SOP for a Medical Device There is no shortage of documentation required when developing a medical device. Standard operating procedures (SOPs) are one essential piece of documentation required to get your medical device approved and on the market. Putting together this documentation can be confusing, but when it is done well,

Some of the medical device technologies in use today might seem more like they fit in a futuristic science fiction movie. Neuroscientists are exploring opportunities to use virtual reality and mind-controlled devices. Children’s hospitals embrace a new way to provide emotional support to their young patients. Cardiac patients can wear a garment to shock their

This article brings a positive perspective on medical device recalls. There is good news and event better news. Medical devices are never perfect. Regulators and manufacturers know that. Processes are in place to ensure innovative devices continue to be developed and, when recalls occur, to make them even better. Should these processes be improved? Yes, continuously improved

While Kai-Lin was ambling along a crowded sidewalk, the breeze whispered, “You’re scared and cannot do this.” Kai-Lin, an evolving leader at the fictional medical device company, Mythical Medical, overheard this as a cruel, merciless, penetrating scream, not a weak, pathetic, faint murmur. She needed help to prepare for an upcoming audit and contacted me

Did you know that the invention of the very first electrocardiograms, external defibrillators, and implantable cardiac pacemakers may have been inspired by the story of Frankenstein? This monster may have helped save millions of lives. The late Medtronic founder, Earl Bakken, was intrigued when, as an eight-year-old child, he watched over and over Mary Shelley’s

If you have a novel idea, it makes sense to protect it. The term medical device covers any type of instrument used to diagnose, manage, or treat a medical condition. It’s a multi-billion-dollar industry covering everything from tongue depressors to insulin pumps and pacemakers. As the digital transformation shapes the future of healthcare, medical devices

The United States (US) Food and Drug Administration (FDA) mandates that medical device manufacturers must comply with quality management systems to guarantee consistency in their products and comply with any specifications or requirements. In the 1960s and 1970s, the US Congress responded to the public’s desire for more oversight over medical devices by eventually passing the Medical