What is in a device history record?
THE FDA MANDATES THAT MEDICAL DEVICE COMPANIES PRODUCE A DEVICE HISTORY RECORD (DHR) THAT CONTAINS ALL DOCUMENTATION RELATED TO MANUFACTURING AND TRACKING THE DEVICE, AND DEMONSTRATES THAT THE DEVICE WAS MANUFACTURED ACCORDING TO THE INFORMATION IN THE DEVICE MASTER RECORD.
Why is design history file important?
The DHF is not only a regulatory requirement but also provides significant value to the manufacturer in understanding development successes and failures, and approaches for new designs. It contains valuable verification and validation protocols that are not in the DMR.
What is medical device file?
Medical device files are documents that includes descriptions of design records, manufacturing processes, product specifications, device usage guides, quality measurement criteria, levels of compliance with regulatory bodies and quality standards, and, if required, servicing and installation records and their …
What is a device master file?
Device Master File means materials that may be used to provide detailed information to the FDA or other Regulatory Body about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of the Products.
What is the batch record?
A batch manufacturing record is a written record that documents the entire manufacturing process and the history of a product batch. In other words, it tells you how to produce a product and records the way that happens.
What is device history Record (DHR)?
The Device History Record (DHR) is outlined in the US FDA Quality System Requirements, Part 820, section 184. The FDA mandates that every manufacturer of a medical device maintains a DHR.
What is the difference between design history file and device master record?
The Design History File explains how you developed the recipe for making your device. The Device Master Record is the recipe itself (specifications, work instructions, inspection procedures,etc.) for making the device. The Device History Record is the evidence according to the recipe. that a particular unit, batch or lot of devices was made
What is a device master record for gloves?
DMR : DEVICE MASTER RECORD Title 21 CFR 820.3(j) states a “Device master record means a compilation of records containing the procedures and specifications for a finished device.” A Device Master Record (DMR) is a comprehensive record of all of the procedures and instructions required to manufacture each type of glove.
What is a device master record (DMR)?
Device master record (DMR) means a compilation of records containing the procedures and specifications for a finished device. It is further discussed in 21 CFR 820.3 (g) Design output.