Posts by Tropical Palm Trees

Instructions for Use (IFU) Specialists A weak IFU can result in, at the very least, a failed Summative Validation Study. 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…