According to RAPS, the new 510(k) ruling by FDA details “how regulators will evaluate applications in order to determine ‘substantial equivalence.'” In the past, medical device manufacturers were able to reference separate but similar devices or products (called predicate devices) that had already been marketed in order to assess the safety of their new device. Read more »

In the business of medical device manufacturing, validating the cleaning process of products is a top priority. You must always ask yourself the two most important questions: will the device be safe for the patient, and will it continue to function properly? If it is not cleaned thoroughly during its production, it could be an issue. Consider these useful tips for validating your cleaning process to help ensure your medical device products will be safe and effective. Read more »