Medical Device SOP Writing and Process Mapping Training
In this class you’ll learn best practices and strategies to plan and improve a documentation control system, gain compliance for electronic records and signatures, and prepare for audits under the European regulations, ISO 13485:2016, and FDA’s QSIT. The course goes beyond compliance by demonstrating that well-written standard operating procedures (SOP) reduce the potential for human error in processes. It also introduces concepts to assist in writing for the audience and designing procedures to reduce cognitive overload and mistakes.