USA Regulatory ServicesHow Medreg Can Support Your DMR Requirements
Medreg provides support to medical device manufacturers in developing, reviewing, organizing, and maintaining Device Master Record documentation in line with applicable regulatory requirements and quality management system practices.
Our support can include:
- DMR Development: Preparing and organizing manufacturing and quality documentation based on device specifications and manufacturing requirements.
- Documentation Gap Assessment: Reviewing existing records to identify missing, incomplete, or inconsistent documentation.
- Manufacturing and Quality Documentation: Supporting the preparation and review of manufacturing procedures, work instructions, inspection plans, testing procedures, and acceptance criteria.
- Device Specifications and Traceability: Helping organize relevant drawings, component and material specifications, packaging requirements, and labeling documentation.
- Document Control and Change Management: Supporting controlled updates to DMR documents following approved design, process, or specification changes.
- QMSR and ISO 13485 Alignment: Helping manufacturers align applicable documentation practices with their quality management system and regulatory obligations.
- DMR Maintenance Support: Assisting with periodic reviews and updates to help ensure that manufacturing documentation remains current and consistent with approved processes.
A well-organized Device Master Record helps establish a reliable foundation for manufacturing consistency, quality assurance, and regulatory compliance.
Contact Medreg to discuss your DMR development, documentation review, and quality management system support needs.
What Is a Device Master Record (DMR)?
A Device Master Record (DMR) is a collection of documents and specifications that defines how a medical device is manufactured, inspected, tested, packaged, and serviced. It contains the information and instructions necessary to ensure that the device is consistently manufactured in accordance with its approved design and established quality requirements.
What Information Should a DMR Include?
The contents of a DMR depend on the device, its manufacturing processes, and applicable regulatory and quality management requirements. Typical documentation includes:
- Device specifications: Drawings, material specifications, component details, formulations, software specifications, and other applicable design outputs.
- Production process specifications: Manufacturing methods, work instructions, equipment requirements, process parameters, and environmental conditions, where applicable.
- Quality assurance procedures: Inspection and testing procedures, acceptance criteria, sampling requirements, and specifications for quality assurance equipment.
- Packaging and labelling specifications: Packaging configurations, labeling requirements, and the procedures used for packaging and labeling operations.
- Installation, maintenance, and servicing procedures: Applicable instructions and methods for installation, maintenance, repair, and servicing of the device.
Additional supporting records and procedures may be necessary depending on the device type, manufacturing activities, and the manufacturer's quality management system.
