Device Master Records (DMR)
Posted by 26/02/2016 0 Comment(s) Quality System,
Device Master Records (DMR)
Things are very raw when a product idea is conceived. In order to organize this initial thought process and keep a record of it, a preliminary compilation of information is required. Generally it is done in the form of a note book, register or loose papers filed together. Though in raw form, this information is critical for a product's lifetime. Information of all subsequent developments keep adding to this compilation in a chronological fashion thus having a complete history. This helps resolve technical issues or complaints by providing an insight into its development chronology.
ISO 13485, the Quality Management System for Medical Devices, makes it mandatory for the organization to maintain a specific file for each model, type, or category of the medical device, describing the medical device specifications, types of raw materials, components, specifications, evaluation and control of a specific medical device, types of raw materials, components, specifications, evaluation and control of a specific medical device. This is referred to as a Technical Construction File (TCF, largely used in context of CE marking) or Device Master Record (DMR). It also demonstrates how the product complies with various functional, statutory and regulatory requirements.
This documents is also important from utility point of view, particularly when the company goes through changes from design-and-development to full scale production stage. It supports with information relating to objective of the medical device, their specifications, procedures, instructions, controls, verifications, and validations etc. DMR also defines the scope of control intended or required on the product such as what is to be controlled, who and how will be controlled, when, where and how long.
As a broad guideline, following documents are typically the part of a DMR, as applicable:
Input specifications: This includes specifications for raw materials, lists of parts and components, appropriate engineering drawings, product drawings, specifications of components, specifications of functions, software specifications, MSDS or test reports
Product specifications: Characteristics of the product, product descriptions, specifications of functions
Production process specifications: Appropriate equipment, machinery and tools specifications and operations, production methods, work instructions, work environment, assembly plans, cleanliness and sterilization processes, quality plans
User instructions, test reports, MSDS of inputs and risk analysis
Quality requirements: Quality assurance procedures and specifications including outputs of risk management activities, list of applicable standards, acceptance criteria, test instructions, inspection procedures, quality assurance equipments to be used, validation plans, packaging validations
Packaging requirements: Packaging and labeling specifications and instructions, packaging methods and processes used, delivery instructions
User instructions, Installation activities and processes. service and maintenance activities and processes