Often overlooked with disastrous results, a weak IFU can result in, at the very least, a failed Summative Validation Study. And more importantly, the FDA and IEC/ISO 62366-1:2015 will not permit medical device manufacturers to mitigate use errors via the IFU. However, a clearly written IFU can help avoid use errors, and provide clear and informative alerts to the user. The Team at RED Group International are experts at creating IFUs that help the user easily understand how to use your device safely and effectively.
RED Group International will evaluate and validate all types of print, electronic and video product labeling, Patient Information Leaflets, and video/print IFUs to ensure the desired message is being conveyed and understood by the user. RED Group International will help you meet all IEC/ISO 62366-1:2015, HE75:2009(R)2013, and FDA 510(k) Human Factors Requirements.
Call us for a free IFU consultation.