Medical Devices | Instructions Manual | FDA Compliances
Instruction manuals or user manuals are very important documents for medical devices and pathology instruments that need to be authored and translated very accurately. These documents are referred by doctors & nurses for the procedures and patient’s treatment. Any errors in user manuals may lead to a very unpleasant situation for the overall treatment and to patient lives.
We are experienced in authoring the IFUs(Instruction for use) or User manual documents as well as in getting these documents translated into 32+ global languages. These documents are designed & authored in a way aligned to standards laid by global regulatory bodies.
We coordinate the complete process of document authoring with multiple departments of the organization of a medical device including R&D, legal, marketing, packaging, and regulatory affair to name a few.