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As IT becomes integral in medical device design, clinical and IT specialists need better communication during the earliest stages of device development, experts said at a recent audioconference hosted by healthcare research group ECRI.
When designing medical devices that use radio-frequency (RF) wireless technology, firms should consider how those products will interact with other devices and respond to potential electromagnetic interference (EMI), the FDA says in new draft guidance.
Optimata, an Israeli company, has signed an expanded collaboration agreement with Eli Lilly under which Optimata will use computer simulations to help the pharma giant narrow down the possible conditions under which investigational new drugs are to be tested, saving effort at both the preclinical and clinical testing stages. Financial terms were not disclosed.
The FDA and the Centers for Medicare & Medicaid Services (CMS) need to base their product approvals and reimbursement decisions on more complete evidence when dealing with costly new technologies such as heart imaging devices, an expert says.
The quality systems approach is as essential when making changes to pharmaceutical and medical device industry software as it is when changes are made to other aspects of the manufacturing process, experts said at a recent conference.
GS1 EPCglobal, the nonprofit standards organization dedicated to promoting worldwide adoption of electronic product codes (EPCs) for supply-chain excellence, said it has ratified the open Electronic Pedigree Document specification.
The FDA wants to create an electronic network to gather and share medical product safety information with healthcare professionals and patients, the agency announced.