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Even though the risk management process is continuous, you can break it down into steps to make it more manageable for you and your team. Let’s explore the steps that should happen after you’ve [...]

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 [...]

Creating a comprehensive traceability matrix hinges on sourcing accurate user, safety, science, and technology needs related to your medical device. Like most companies, your firm is probably [...]

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 [...]