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When it comes to leading a startup, one of the most relevant and frequent conversations is about securing funding. Common questions such as how long will it take to raise and how much is needed are typically the first to come up. However, the most crucial question organizations should ask themselves is how they can make themselves more attractive to investors.
There are estimated to be 5,300 to 5,600 medical device companies in the United States alone, each with new, cutting-edge technologies. However, as advanced as these devices must be, above all else, they must operate safely. The International Organization of Standardization (ISO) developed the standard ISO 13485, which provides guidelines around the quality management of medical devices. Although ISO 13485 is helpful as a harmonized standard, there’s one catch.
A few months ago, the FDA released a guidance on medical device reporting (MDR), an important document with which manufacturers should familiarize themselves. It outlines expectations of reporting, and it is a vital part of post market surveillance. I recently had a chat with Mike Drues, president of Vascular Sciences, about MDR and what it means to medical device companies. What isn’t MDR, and why is it important? The following are a few of our thoughts on the state of MDR.
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