FILE DESIGNATION
Device Master Record (DMR) is a set of documentation and specifications
that describe the methods and processes used to produce a medical device.
It includes everything necessary to manufacture, test, and ensure the quality
of a medical device. The DMR includes:
1. Device Specifications: Detailed drawings, compositions, and other
specifications that define the device's design.
2. Production Process Specifications: Step-by-step instructions for
manufacturing, including equipment and tools to be used, production
methods, and environment controls.
3. Quality Assurance Procedures and Specifications: Instructions for
testing, inspection, and quality control, including the acceptance
criteria for materials, components, and finished products.
4. Packaging and Labeling Specifications: Information on how the
device should be packaged and labeled, including any regulatory or
safety labeling requirements.
5. Maintenance and Servicing Procedures: Instructions for the
maintenance, servicing, and repair of the device, if applicable.
Design History File (DHF) is a collection of records that document the
design and development process of a medical device.
Key components of a DHF typically include:
1. Design and Development Plan: An overview of the design process,
including timelines, milestones, and responsibilities.
2. Design Inputs: Requirements and specifications that the device must
meet, including user needs, safety standards, and regulatory
requirements.
3. Design Outputs: The final specifications, drawings, and
documentation that reflect the completed design. These outputs must
meet the design input requirements and include details such as
manufacturing instructions, assembly drawings, and software code.
4. Design Reviews: Documentation of formal reviews conducted at
various stages of the design process to evaluate progress, identify
issues, and ensure that the design meets the specified requirements.
FILE DESIGNATION
5. Design Verification: Evidence that the design outputs meet the
design inputs. This may include test results, inspections, and other
forms of verification.
6. Design Validation: Evidence that the final product meets the
intended use and user needs. Validation activities may include clinical
trials, usability testing, or other assessments in real-world conditions.
7. Design Changes: Records of any changes made to the design
throughout the development process, including the rationale for the
changes and their impact on the design.
8. Risk Management: Documentation of the identification, assessment,
and mitigation of risks associated with the design of the device.
Design History File (DHF) is a comprehensive collection of records that
document the design and development process of a medical device. It serves
as evidence that the device was developed in accordance with the design
plan and regulatory requirements, particularly those outlined by the U.S.
Food and Drug Administration (FDA) under the Quality System Regulation
(QSR).
Key components of a DHF typically include:
1. Design and Development Plan: An overview of the design process,
including timelines, milestones, and responsibilities.
2. Design Inputs: Requirements and specifications that the device must
meet, including user needs, safety standards, and regulatory
requirements.
3. Design Outputs: The final specifications, drawings, and
documentation that reflect the completed design. These outputs must
meet the design input requirements and include details such as
manufacturing instructions, assembly drawings, and software code.
4. Design Reviews: Documentation of formal reviews conducted at
various stages of the design process to evaluate progress, identify
issues, and ensure that the design meets the specified requirements.
5. Design Verification: Evidence that the design outputs meet the
design inputs. This may include test results, inspections, and other
forms of verification.
FILE DESIGNATION
6. Design Validation: Evidence that the final product meets the
intended use and user needs. Validation activities may include clinical
trials, usability testing, or other assessments in real-world conditions.
7. Design Changes: Records of any changes made to the design
throughout the development process, including the rationale for the
changes and their impact on the design.
8. Risk Management: Documentation of the identification, assessment,
and mitigation of risks associated with the design of the device.
