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Ultimately risk is not a simple matter. There are many different connotations of risk.
Medical device manufacturers need to understand the impact of risk mitigation strategy on a regulatory submission as it can make or break a submission, especially if it’s a 510(k) or de novo.
Your risk management plan is also very important, not just to meet the design control requirements, but in terms of product liability, as well.
A successful medical device manufacturer must carefully consider not only what you say regarding risk and how you say it, but also what you don’t say and how you don’t say it!