Using online platforms like Twitter, Facebook, Tumblr, LinkedIn, and others is a standard component of communicating with consumers in today’s business. And, it’s no different for drug and medical device manufacturers. In the life sciences [...]

Every manufacturer must meet a set of design control regulations given by the FDA for each medical device they produce. An important part of the product manufacturing process, each of these design control requirements must [...]

Risk management is one of the most important parts of the manufacturing process when it comes to developing safe, effective, and beneficial medical devices. Your company needs to implement risk management at all levels in [...]

For medical manufacturers, compliance with the FDA regulations is paramount, as the device or product itself as well as the manufacturing process must all meet these specific standards. With the rise in mobile medical apps [...]

For medical device managers, it is that time of the year when precautions should be especially considered. Medical products have international standards which must be complied with if these devices are to be internationally used [...]

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 [...]