H
hlg1102
Hi Forum,
We are currently an initial distributor of a Class I video laryngoscope device in the US from a UK manufacturing company. 820.30 states specific design control requirements, but only for certain class I devices. Since releasing the device into the market, it has undergone some manufacturing upgrades. Should the design control requirement be considered?
We are currently an initial distributor of a Class I video laryngoscope device in the US from a UK manufacturing company. 820.30 states specific design control requirements, but only for certain class I devices. Since releasing the device into the market, it has undergone some manufacturing upgrades. Should the design control requirement be considered?