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...2 Medical Device Labeling Challenges ...3 Anticipating Regulatory Change ...
Digital health is a rapidly growing field. As it expands, so must the security of medical devices, especially in an increasingly vulnerable digital space. While the various features and advantages of the connections in healthcare services are undeniable, they also bring security considerations. The ...
as a matter of company policy, to their R&D engineers, “If you’re going to change a device, only change it to the point that we can handle that change internally, doing what we call a letter-to-file. Do
Despite the best intentions of procurement, changes in the availability of material grades can be imposed by suppliers. This might be a result of new regulations or simply strategic changes on the part of the supplier. A long-running device may be subject to multiple changes over its lifetime...
It is crucial that organizations maintain a medical device inventory database to reference while responding to a security incident. CSA also recommended that organizations classify devices based on clinical considerations and the potential impact of the device going offline in order to qu...
Although also the EU medicinal products regulatory system has its own issues (which is why it is radically revised at the moment to fix these by the way) it is much better developed in the field of legality aspects as referred to in the WTO recommended good regulatory practices for medical ...
Our Medical Affairs Consortium provides Medical Leaders with on-demand data, operational insights, and best practices which enable evidence-based problem solving and continuous improvement. Armed with these critical insights, our client members embark on a yearly ongoing networking and performance ...
Nonetheless, teams are still the best mechanism for dealing with the primary task at hand-improving patient outcomes. A virtual wealth of knowledge has been created in the human factors and occupational sciences concerning the myriad ways in which team performance may be optimized. In addition, ...