P2.3 Verification of design and Specs.

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 [...]

In case you missed it, we hosted a webinar Tuesday, November 6th.  No need to worry, you can read the transcript below or fill out the form below and see the video. Our entire U.S. healthcare [...]