As you go through the design and development process for your medical device, the documentation that you create will be contained in your design history file, commonly abbreviated as DHF. The design history file shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part.
This means that any material proving your device is compliant should be included in your DHF. Trying to build out your DHF after the fact makes organizing your documents harder. Instead, treat your DHF as a living document that you update throughout the design and development process of your device. You need to include or provide a reference to all of the records related to the activities that took place during design and development. Design verification and validation protocols and reports.
Design reviews associated with user needs, design inputs and outputs, and design verification and validation protocols.
All materials relevant to design transfer into manufacturing. A DHF can take up several binders of physical documents with paper systems, or span hundreds of rows and columns across multiple Excel workbooks with digital paper solutions. Finding any individual document or adding a new one after the fact will be slow and tedious. These ad hoc systems also make it easy for documents to get lost, duplicated, or mixed up alongside outdated versions. A purpose-built QMS solution can save teams a considerable amount of time, serving as the guardrails to prevent mistakes from happening throughout the design and development process.
Full traceability of all connections between user needs, design inputs and outputs, verification and validation, and design reviews is simplified with an eQMS that provides a clear, well-designed user interface and experience for teams. The process of accessing and compiling the DHF takes far less effort than it does on paper. What is a sprint medley? Is a DMR a sniper rifle?
What does DMR stand for in pharmacy? Direct Member Reimbursement. What is DHR in manufacturing? What is master record? What are design inputs? What is the full form of DHR? Is DHR a government agency? What is a device history record? Similar Asks. Popular Asks. See All Resources. Ready to learn more about working with us? Contact Us. Chat with us. After obtaining FDA approval, the OEM can move forward and start manufacturing the product in-house or entrust an experienced contract manufacturer like Sanbor Medical.
We will work with the OEM during the process to ensure the next set of records are managed in accordance with FDA requirements. DMR Device Master Record : a compilation of the procedures and specifications for making the finished device and testing it, including design specifications drawings, composition, formulation, component and software specifications , process documents, tools and tooling specifications, production methods, environment specifications, inspection procedures, quality assurance acceptance criteria, QA equipment , labeling and packaging, and service details.
Many of these files should be already available if a proper DHF was created, and they can be simply referenced here. The focus is to ensure that the manufacturer has all of the necessary items to build, test, package, and maintain the device.
Includes: lot s or UPCs important for complaint investigations , manufacturing dates, quantity manufactured and distributed, acceptance records that show the design followed the DMR, and labeling for each unit. If a contract manufacturer is used during this process, the DHR has to specify who reviews and releases the product.
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