I agree with aaq2 in respect to mitigation being the best strategy for countering high severity risk. I do not agree with the fact that risk acceptance is wise option based off cost of acceptance being less than the cost of mitigation. Perhaps in the short term the cost of mitigation may be greater compared to risk acceptance, however in the medical device industry a high failure rate for a product can leave a stigma on a company and in the long run the avoidance strategy will cost potential new customers, as quality of the product won’t be seen as comparable or better than others on the market.