Medical device organizations are continuing to sharpen their focus on developing high-quality medical devices aimed at improving patient outcomes. However, many struggle with effectively managing requirements and traceability across the product development lifecycle. This can be costly, risky, and lead to delays in new product introductions when considering the increased complexity in medical products, competition, and the regulatory landscape.
Axendia conducted a research study focusing on the medical device industry’s approach to requirements management with a goal to identify and analyze the drivers, barriers, trends, and value of requirements management across the product development lifecycle.
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