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MD&M West 2014: What do you do when regulatory requirements exceed that of reasonable engineering controls?
We all have the same goal: a safe medical device. Occasionally, the regulatory and company requirements are the same. The practice of medicine may result in each global regulatory body having requirements that differ from the company requirements. These differences will need to be reconciled to gain approval.
MD&M West 2014: What do you do when regulatory requirements exceed that of reasonable engineering controls?
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