Medical Device Software: Risky Business
By: Ranica Arrowsmith, Editor
From: Medical Products Outsourcing
March 13, 2014
As medical device software developers continue to innovate, security and risk management concerns remain.
Risk Management and Quality Assurance
Security is just as important as software outside the medical device as inside it. Software made for electronic health records, medical device manufacturing process, and any number of other healthcare systems that don’t come into direct contact with the patient, has its own host of security concerns to consider.“Security for software used in a highly regulated industry such as medical devices is critical, especially as it relates to 21 CFR [Code of Federal Regulations] Part 11,” Deborah Kacera, regulatory & industry strategist at Pilgrim . . .
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