I was called in to work with a major manufacturer of medical device following a formal citation by their notified body for a non- conformity in their clinical evaluation report, specifically pertaining to the state-of-the-art analysis for their product.
In today’s competitive climate, it is critical that products meet or exceed the key performance metrics of the market leaders. Not content with anecdotal data, I recently worked with a major medical device manufacturer to thoroughly review and compare the safety and performance of their surgical devices to a major competitor.
I have been working with a client for several years helping him stay one step ahead of his competitors. It was important that I understand the competitive nature of his business so that I could help my client become more competitive.