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The medical device industry is highly regulated. For good reason. These regulations exist to protect patients and consumers by ensuring the safety and efficacy of medical devices. Of course, [...]

The process of developing a new medical device is overwhelming. The sheer volume of logistics and requirements makes it extremely challenging to anticipate and plan for each of the many steps [...]

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 [...]