Company: Daavlin Distributing Company Date of Enforcement Report: 5/18/2022 Class II PRODUCT 1 Series CX phototherapy units equipped with Daavlin’s ClearLink Control System software versions v3.03h and 3.04v. Models: 1 Ser CX 305-4 120-240V 50/60Hz, item # 06OS0004CX6 1 Ser CX 311-4 120-240V 50/60Hz CE, item # 807OS0004CX5 1 Ser CX 311-4 120-240V 50/60Hz, item...Read More
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Updated Risk Management training course now available. Includes:
Coverage of ISO 14971, IEC 62304; amd1, and IEC/TR 80002-1.
Why FMEA is incomplete for medical device risk management.
