From device conception through decommissioning risks are appearing, and must be managed. The review of an IVD-Analyzer’s journey provides some interesting insights, a walk across the company’s organization, its quality management system, and the markets served.
Learnings: - Be open to all sort of triggers for risk analysis! - Insights to Software Life Cycle Processes acc. IEC 62304 - Specifics of Risk Management for In-Vitro Diagnostic Medical Devices (IVDs)
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