MAE Group offers target services and expertise that translate into an efficient and economical fast-track to global markets. Whether your company is your company is experiencing a bandwidth shortfall or you need a specific skill set, MAE Group offers you that expertise. Trust MAE Group to handle every aspect of independent regulatory, quality systems, design […]
Blue Chip Solutions Read More »
Solutions
Whether you’re a small or medium size enterprise, MAE Group Solutions has you covered. MAE Group provides comprehensive regulatory, quality, design, clinical, and project management expertise to see your product through to final clearance or approval. We assist in the global commercialization of medical and in vitro diagnostic devices, OTC and Pharma Rx.diagnostic devices, OTC and
Small & Medium Enterprise Solutions Read More »
Solutions
MAE Group is the capstone between the inventor and investor. We offer a full bespoke suite of commercialization services to early-stage companies. Our teams will efficiently get you through the commercial process, maximize the inventor’s exit strategy, and de-risk the investor’s funding exposure. We bring medical device and in vitro diagnostic device technology to global
Early Stage Solutions Read More »
Solutions
Regulatory device compliance
3 Keys to Understand Regulatory in Med Device Read More »
News & Blog
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
Success Story: NeoGuard – Developing a Truly Life-Saving Device Read More »
News & Blog, Quality System Management, Success Stories
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
What is risk-based thinking in the medical device industry? Read More »
News & Blog
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
A Journey of Hope: The Story of a Small Company with a Big Vision Read More »
News & Blog, Project Hope
“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
Honoring Dr. Dario Rodrigues Read More »
News & Blog, Project Hope
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
Joining the Fight Against Cancer Read More »
News & Blog
