ISO 13485 has undergone its first major overhaul of manufacturing system requirements since 2003. Over the next three years, both the previous requirements and 2016 requirement will co-exist, [...]
Blog Home TAG: Risk Management
In Archives, Medical Device Industry, FDA Regulated Industries, Quality Management, Regulatory Compliance Management, Risk ManagementPosted
A new FDA guidance concerning risk management helps medical device manufacturers meet expectations regarding an effective postmarket cybersecurity program. Cybsersecurity: Patient Safety, Product [...]
In Archives, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk ManagementPosted
Risk management remains a key focus of the FDA. A revised FDA guidance offers new details and hones the scope previewing the agency’s pilot test of a risk-based system to track data submissions [...]
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