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.
In this research report conducted by Axendia, a leading Life-Sciences Analyst firm, and presented by Jama Software, we walk through groundbreaking new research about the costly impact of ineffective requirements management in the medical device industry, including:
-
The impact of having an ineffective closed-loop requirements management process.
-
The critical importance of requirements management to achieve improved patient outcomes, product quality, and time to market.
-
The negative impact on budgets, traceability, verification, and validation activities when relying on manual processes
