What is a DHR?

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.

What is DMR and DHR?

DHR – Device History Record

Date(s) of manufacture. Quantity manufactured. Quantity released. Acceptance records demonstrating compliance with the DMR. Primary identification label and labelling for each unit.

What is the purpose of design history file?

The Design History File is a collection of documents that describe the design and development activities of a medical device. Its purpose is to demonstrate that the device was developed using the design control process needed to meet FDA requirements.

What is a design master record?

A Device Master Record (DMR) is a compilation of all the instructions, drawings and other records that must be used to produce a product. The term is used in Quality Management Systems that cover product design and production.

What is device master file?

Device Master File means materials that may be used to provide detailed information to the FDA about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of the Products or Material.

What is Ham DMR?

DMR stands for Digital Mobile Radio and is an international standard that has been defined for two-way radios.

What is the DMR process?

The DMR Method (Diagnose, Manage and Rehabilitate) is a specific course of evaluation and treatment based on years of clinical case study research utilizing pre- and post-treatment MRI scans and functional index scores (which track a person’s ability to engage in normal physical activities).

What is a master record index?

The Master Record Index – ILS (MRI-ILS) defines the standard of build of the Equipment. The index comprises a key to the approved drawings and associated records and lists all design changes introduced by amendments and modifications. The MRI-ILS is used by the Supplier to define the Equipment.

Which documents should be part of your Design History File or technical dossier?

The DHF shall contain or reference the records Necessary to demonstrate the design did what developed in accordance with the approved design plan and the requirements of this part.” Documents that should be included in a Design History File are: Design inputs such as a system or software requirements specification.

What is DMR for back pain?

DMR is short for Decompress, Mobilize, and Rehabilitate. After years of studies from passionate and curious individuals in the chiropractic, physical therapy, and surgical industries, the DMR method provides a non-surgical approach to facing this type of pain.

Is Bom part of DMR?

A device master record (DMR) is the compilation of all the information used to produce a device. It contains the bill of materials (all the materials used to construct a product) and the bill of operations (all the processes used to manufacture, distribute, and service the product).

What must the device master record 21 CFR 820.181 include?

According to FDA Title 21 CFR Part 820.181, what must the device master record include? The device master record must include: Device specifications (i.e., drawings, composition formulation, component specifications, and software specifications) … Packaging and labeling specifications.