Ultrapure dialysis fluid for hemodialysis and related therapies
Document status: Active
Non-invasive blood pressure motion artifact - Testing and evaluation of NIBP device performance in the presence of motion artifact
Document status: Active
Guidance on the use of agile practices in the development of medical device software
Document status: Active
Guidance on the use of agile practices in the development of medical device software
Document status: Active
Quality Management System (QMS) guidance on compliance with FDA's Final Rule on combination products
Document status: Active
Design of training and instructional materials for medical devices used in non-clinical environments
Document status: Active
Post-market surveillance of use error management
Document status: Active
Human factors engineering - Guidance for contextual inquiry
Document status: Active
Environmental Monitoring For Terminally Sterilized Healthcare Products
Document status: Active
Guidance for the development, validation and routine control of an ethylene oxide sterilization process utilizing flexible bag systems for the sterilization of medical devices
Document status: Active
