Medical devices undergo a strict and rigorous evaluation by the Food & Drug Administration (FDA) to obtain approval for the US market. Suppose you want a Class II medical device cleared for sale in America. In that case, you need to be familiar with predicate devices (predicates) and how to support your substantial equivalency claims with carefully crafted documentation.  Read More

Your regulatory strategy determines whether your 510(k) submission clears the FDA or dies on the vine. It is the deciding factor in how long clearance takes: from 90 days to over six months. Lost months mean lost revenue and re-tasking resources that could be spent on other revenue-generating activities.  Read More

The medical field is continually evolving, and nowhere is that trend more evident than in the realm of medical devices. From wearable medical devices to increasingly smart data infrastructure, technology will take center-stage in 2021.  At the same time, regulatory bodies like the US Food and Drug Administration (FDA) are developing new guidelines to manage the increased reliance on these... Read More

The EU Medical Device Regulation (EU MDR) requires more than a few new SOPs. A profound overhaul of the regulatory approach in one of the world’s largest medical device markets, the EU MDR demands new procedures, evidence development, documentation, relationships, reporting, data management, and a reevaluation of legacy portfolios. Read More

The United States of America is the largest medical device market in the world. A population’s age is a good indicator of how high the need for medical devices will be in the coming years. As the United States’ “Baby Boom” population(those born in the years 1946-1964) continues to age, the medical market is projected to steadily increase.  Read More

Product recalls are an unfortunate part of any manufacturing industry. For medical devices and pharmaceuticals, recalls are serious affairs requiring swift corrective action. Each year, an average of 4,500 drugs and devices are removed from the market due to recall. In 2017, the FDA identified more than 30 Class I recalls, where further use of the product could result in serious injury or death.... Read More

When it comes to health, prevention is naturally preferred to treatment. For stroke victims, recent medical device advances are providing the hope of preventing future attacks. Both the Watchman (approved for Boston Scientific by the FDA in 2015) and the Amplatzer PFO Occluder (approved for St. Jude in 2016) work to stop blood clots from reaching the heart and are already being used with success.... Read More

In 2016, the ever rising cost of healthcare generated some of the most intense public and political debates. Perhaps in no way was this better summarized than the sudden – and shocking – rise in the price of the EpiPen, a life-saving device dispensing epinephrine for the severely allergic. From a price of $100 in 2007, the cost skyrocketed to over $600 last summer. Consumers were outraged,... Read More

Additive manufacturing, more commonly referred to as 3D Printing, appears set to have a major impact on medical device manufacturing. Pricing on the printers themselves has dropped steadily over the last several years, even while the technology behind them has become more refined. Read More