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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 [...]

  If your medical device is reusable, a method for cleaning and disinfection must be specified by the medical device manufacturer as well as instruction for users on how to clean it. These [...]

Within medical device companies, a dedicated team — either quality assurance (QA) or verification and validation (V&V) groups — is often tasked with ensuring that products in development meet [...]

    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 [...]

After months of allocating resources to your new product development project, it has moved into the validation process and user testing. There is the knock on your door and your team approaches [...]