Developers have created a Google Glass app that guides surgeons through an implant procedure.
MDDI
MDDI
Simplifying Global Compliance
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GMP Inspection Preparation Checklist: A Tool for Internal Auditing
This management report includes more than 650 items organized in three sections covering all aspects of quality manufacturing.
Biological Risk Evaluation and Management for Medical Devices
Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.
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Senators Question Digital Health Pre-Cert Program
The agency “should be focused on ensuring it has the tools and capacity to guarantee that software products that perform medical device functions are safe and effective and to hold companies that skirt the rules accountable,” the letter states.
Pfizer Gets FDA Nod for Breast Cancer Drug
The agency based its approval on the results of a 431-patient trial.