FREE ON-DEMAND WEBINAR
Risk mitigation in the medical device industry typically starts with a brainstorming session: the product development team randomly rattles off risks and writes them down.
This “cherry-picking” approach is a haphazard process because whether you spend an hour or a year, you can never be certain you have captured all the important risks.
Suffice it to say, this webinar is not the typical ISO 14971, QMS or Design Control approach which although commonly followed, all take a very limited view of risk and are simply not adequate for regulatory submissions.
During this free 90 minute interactive webinar, a more systematic, engineering-minded approach to risk is presented.
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!