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Risk management is a crucial aspect of medical device development. You need to account for and mitigate the risks associated with your product early on, so it’s safe for users and passes [...]

Medical device regulation gets more stringent all the time. It’s harder to get FDA approval now than it was just five years ago. For good reason.

Patient safety and reducing hospital stays is the priority for healthcare institutions and one of the focus areas is preventing patients from getting HAIs (Healthcare-associated infections) [...]

Nothing about launching a new medical device is simple. From the FDA’s regulatory requirements to usability testing, medical device development can seem downright byzantine. Unfortunately, the [...]

Patient safety and reducing hospital stays is the priority for healthcare institutions and one of the focus areas is preventing patients from getting HAIs (Healthcare-associated infections) [...]

If you’re thinking of bringing a new medical device to the market, you probably already know that your first step is to determine whether or not you need to follow the FDA’s Design Controls. If [...]