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A collection of featured documents from our library that are popular among our users or otherwise noteworthy.
Medical device software—Part 1: Guidance on the application of ISO 14971 to medical device software
Medical Devices - A Practical Guide
Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
Sterilization of health care products—Radiation—Part 4: Guidance on process control
Medical devices—Guidance on the application of ISO 14971
Medical device software—Part 2: Validation of software for medical device quality systems
Standard for medical device security—Security risk management for device manufacturers
U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems
Guidance on transferring health care products between radiation sterilization sources
Risk management guidance for combination products
Microbiological methods—Understanding and use of product bioburden data
External transport of reusable medical devices for processing
Selection and use of protective apparel and surgical drapes in health care facilities
Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers
Contract sterilization using ethylene oxide
Physical aspects of ethylene oxide sterilization
Microbiological aspects of ethylene oxide sterilization
Compatibility of materials subject to sterilization
Guidance on electromagnetic compatibility of medical devices in healthcare facilities
Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE'
Guide for process characterization and control in radiation sterilization of medical devices
A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
Water for the reprocessing of medical devices
Application of ISO 14971 to machine learning in artificial intelligence—Guide
Sterilization of health care products—Radiation sterilization—Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits