Company: Normand-Info S.A.S.U. Date of Enforcement Report: 6/16/2021 Class II PRODUCT Normand Remisol Advance Data Manager is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments. Recall Number: Z-1831-2021 REASON Instructions For Use for software versions 1.5 to 1.9 did not provide sufficient instructions regarding the proper programming and testing of...Read More

New to medical devices and need an orientation of the creation of instructions for use (IFU)?  A good place to start may be a website prepared by Ferry Vermeulen, a director at INSTRKTIV.  In further preparation for the Medical Device Regulation (MDR) enforcement in the EU, Ferry prepared a guide on how to create IFU for...Read More