HealthCanada released “Guidance Document for Mandatory Problem Reporting for Medical Devices” on October 3, 2011. Mandatory problem reporting is intended to “improve monitoring and reduce the recurrence of incidents related to medical devices.” A mandatory problem report is required for any incident involving a medical device when the incident “relates to a failure of the...Read More
Schedule Discussion with John F. Murray, Jr.
John is currently providing telephone and face-to-face meetings to discuss: Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.
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