3 Keys to Understand Regulatory in Med Device
Regulatory device compliance
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News & BlogNews & Blog
Success Story: NeoGuard – Developing a Truly Life-Saving Device
The neoGuard, a first-of-its-kind wearable device vital signs monitor, launched in 2021 in Kenya, Africa. Designed specifically for regions with unreliable electronics and limited resources, neoGuard monitors vital signs in newborns and can alert nurses and doctors of signs of distress, thereby decreasing infant mortality. The neoGuard is the product of a pair of scientist
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News & Blog, Quality System Management, Success Stories
What is risk-based thinking in the medical device industry?
What is risk-based thinking in the medical device industry? Why is it essential? Around 4,500 drugs and medical devices are pulled from shelves across the United States each year. This alarming statistic highlights the importance of controlling and mitigating risk in the medical device industry. For years regulatory guidance and standards like ISO 14971 have
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News & Blog
A Journey of Hope: The Story of a Small Company with a Big Vision
It’s rare for a small Medical Device business services provider to take on the commercialization of their own medical device. And that sort of challenge is not at all what Janet Kwiatkowski (CEO of MAE Group) intended when she founded the company in 2013. Her original intention was more focused on helping other companies provide
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News & Blog, Project Hope
Honoring Dr. Dario Rodrigues
“Cancer is relentless, so we must be relentless too.” Relentless: oppressively constant; incessant. Cancer never relents as it spreads through the individual’s body, or the collective population. Dario Rodrigues knows this well. In fact, he’s relentless in his dogged pursuit of innovation in cancer treatment: hyperthermia, which promises to be a valuable weapon in the
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News & Blog, Project Hope
Joining the Fight Against Cancer
Female CEO takes the reins to get glioblastoma oncology device to the world That single word whispered by a doctor, “glioblastoma” changes everything. Glioblastoma, a long and complicated word to describe the most common and most aggressive brain cancer. Every year around 12,000 men, women, and children in the United States are diagnosed with this
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News & Blog
Learning from Mistakes is Essential
Learning from mistakes allows your company to successfully see your product to market. Learning from mistakes, yours and others, remains an essential component to successful completion of the commercialization process. Your end goal is to bring your lifesaving device to market impacting countless lives. You want to bring your life saving device to market. Period.
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News & Blog
How to Amplify your Team
Growing your team to be the best and most effective seems challenging especially as an executive, manager, or team leader. However, by using the model of a growth mindset, a company and team becomes the most effective and integrated team possible. A growth mindset is the belief or view that the brain can grow. A
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News & Blog
Medtech Rushing Wastes Time
We’ve all seen it on television: a careful, methodical turtle taking one cautious step at a time. Very. Slowly. Meanwhile, a rabbit nearby is rushing, then maybe napping, but always losing the race. We might cheer for the turtle or the rabbit, but we all know who wins in the end. The turtle, of course.
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