Can YOU help? --> Unanswered questions <-- (Other than Marcelo's Informational posts)

What to expect when moving to higher-risk medical devices?

Hi Everyone,

I'm relatively new to medical devices and kind of got thrown into the deep end in March 2017. So far, so good. We only sell medical examination gloves at the moment, so it seems we don't get that much attention from regulators and the processes are not too complex. But what should I expect if we move into the higher risk classes? Software as a medical device? How will things change?

Thanks in advance.

Marcelo Antunes

Addicted to standards
Staff member
Requirements and oversight (including audits, market surveillance, etc.) will be tougher (not sure how to answer in any other way than generally).

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