Simplifying Global Compliance
Articles Tagged with ''Technology''
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. Read More
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will interact with other devices and respond to potential electromagnetic interference (EMI), the FDA says in new draft guidance. Read More
The medical device industry is catching up to other industries in the area of automation for more efficient manufacturing. Read More
A U.S. and a UK firm recently launched a new database they say should help firms develop new devices more efficiently. Read More
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. Read More
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. Read More
Pharma companies don’t have to wait for root-cause investigations to start making quality products. Read More
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. Read More
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. Read More
The FDA wants to create an electronic network to gather and share medical product safety information with healthcare professionals and patients, the agency announced. Read More
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