Due
to the length of this topic, this blog is divided into two sections, I and II.
1) Basically, Device
Master Record (DMR) is a catalog and compilation of device-specific
documentation required for the procurement of materials and components,
manufacture, and evaluation of the device. DMR is also a compilation of current
records and the status of the physical and software configuration of the device.
A unique DMR is established for each type or
model (family) of medical device manufactured by the company.
2)
Types
of Documents included in DMR
For each type or model of medical device, the
DMR includes the following types of documents. However, not all types of
documents specified in this section are totally relevant for each type or model
of device. For a particular device, the individuals responsible for
Engineering, Production, Regulatory and QA decide jointly which specific
documents are to be included in the DMR.
Note: all these documents should be in the
final form, initialed and dated by responsible parties. Each document must have
a unique identification for traceability.
2.1. Device Specifications shall include, but not limited to
the
following:
§ Trade and Common names
of the Device;
§ Intended Use/Uses of
the Device;
§ Performance Characteristics
and Theory of Operation of the Device;
§ Physical Characteristics
of the Device like size and weight;
§ Environmental Limitations
of the Product;
§ Product Stability of
the Product;
§ Storage Requirements
like temperature and humidity;
§ User Safety Characteristics;
§ Component, Subassembly
and Assembly Drawings and Specifications;
§ Bills of Materials
(BOM); BOM must be detail and organized properly;
§ Compositions and Formulations;
What type of materials;
§ Wiring, Piping,
Electronic and Engineering Drawings;
§ All Related Software
Information.
2.2 Manufacturing Process Specifications: This
is mainly to
show how this product is being made,
examples are shown
below:
§ Process Flow Charts,
Manufacturing Site and its Flow;
§ Process/assembly Lines Diagrams;
§ Manufacturing
Instruction of the Products:
§ Equipment, Tools and Molds
requirement to make this product;
§ Manufacturing Environment
Specifications such as cleanroom specification;
§ Setup procedures for
equipment, tool and molds;
§ Operator Instructions;
§ Equipment Maintenance
procedures like preventive maintenance and its schedule.
§ Validation reports for special
processes like IQ/OQ/PQ of processes.
§ Sterilization
specifications, procedures, and validation reports like Gamma, ETO or E-beam
sterilization.
§ Blank work orders,
nonconforming product/process forms, and other reporting forms.
2.3 Quality Assurance Procedures and Specifications:
· Quality System Manual
both Hardcopy and Softcopy;
· Quality System Operational
Procedures. There should have many procedures for this operation.
· Quality System Forms
like forms for CAPA and non-conforming products.
· Process Control Specifications/Charts;
· Control Plans, Instructions
and Acceptance Criteria for Incoming, in-process, and finished device
inspection and testing;
· Procedures and Acceptance
Criteria for the Verification of Packaging, Labeling, Installation, and Servicing
Activities;
· Blank Work Order forms
for Recording Inspection/testing activities, traceability, and other data for
device history records;
· Device Release Review/evaluation
checklists.
2.4 Packaging and Labeling Specifications of Device:
§ Package Drawings and Specifications;
§ Filling/Packaging
procedures;
§ Label/Labeling
drawings;
§ Instruction or
direction for use manuals. This must be the latest and shall be updated as new
information becomes available.
2.5 Installation, Maintenance, Training and Servicing
Specifications:
§ Installation, Specifications
and Instructions for the Device;
§ Maintenance Instructions
for the device;
§ Servicing Specifications
and Manuals.
§ Training Documents.
Reference
|
Criteria
|
21 CFR 820.181
|
Has
the company maintained device master records (DMR’s)?
|
21 CFR 820.181
|
Has
the company ensured that each DMR is prepared and approved in accordance with
Document Control requirements?
|
21 CFR 820.181 (a)
|
Does
the DMR for each type of device include, or refer to the location of, device
specifications including appropriate drawings, component specifications, and
software specifications?
|
21 CFR 820.181 (b)
|
Does
the DMR for each type of device include, or refer to the location of,
production process specifications including the appropriate equipment
specifications, production methods, production procedures, and production environment
specifications?
|
21 CFR 820.181 (c)
|
Does
the DMR for each type of device include, or refer to the location of, quality
assurance procedures and specifications including acceptance criteria and the
quality assurance equipment to be used?
|
21 CFR 820.181 (d)
|
Does
the DMR for each type of device include, or refer to the location of,
packaging and labeling specifications, including methods and processes used?
|
21 CFR 820.181 (e)
|
Does
the DMR for each type of device include, or refer to the location of, device
specifications including appropriate drawings, component specifications, and
software specifications, and installation, maintenance and servicing
procedures and methods?
|
Disclaimer:
Although
the author had exhaustively researched all sources to ensure the accuracy and
completeness of the information contained in this blog, but no warranty and
fitness is implied. I assumed no responsibility and implied warranty of any
kind for errors, inaccuracies, omission, or any inconsistency herein. No liability
is assumed for incidental or consequential damages in connection with the use
of the information contained herein. Readers should always use their own
judgment and review all related regulatory guidelines. Guidelines can change
over time.
