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Device Master Record Index: Sl. No. Document No. Device Specifications (DS)

The document is a Device Master Record Index that contains specifications for a medical device. It lists 6 key documents: 1) Device Specifications, 2) Manufacturing Process Specifications, 3) Quality Assurance procedures, 4) Packaging and Labeling specifications, 5) Installation, Maintenance and Servicing specifications. Each document section describes the contents and information contained in that document for quality control and regulatory compliance purposes.

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109 views

Device Master Record Index: Sl. No. Document No. Device Specifications (DS)

The document is a Device Master Record Index that contains specifications for a medical device. It lists 6 key documents: 1) Device Specifications, 2) Manufacturing Process Specifications, 3) Quality Assurance procedures, 4) Packaging and Labeling specifications, 5) Installation, Maintenance and Servicing specifications. Each document section describes the contents and information contained in that document for quality control and regulatory compliance purposes.

Uploaded by

normal
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as XLSX, PDF, TXT or read online on Scribd
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DEVICE MASTER RECORD INDEX

Device Name:

Sl. No. Document No.


Device Specifications (DS)

Manufacturing Process Specifications (MP)

Quality assurance procedures and specifications (QA)


Packaging and labeling specifications (PL)

Installation, maintenance and servicing specifications (IMS)


DEVICE MASTER RECORD INDEX

Document Title Approved by


Device Specifications (DS)
Intended use
Product Requirements Document (PRD)
System Architecture document
Software Requirement Specifications (SRS)

Bill of materials (refers to the drawings, specifications,


design document, data sheets of all the components)

Software Output(executable files for software or firmware)


anufacturing Process Specifications (MP)

General Manufacturing description


(Manufacturing process, environment, Contract
Manufacturer's reference,...)

Product process flow chart

Product assembly process/diagram

Equipments and production tools


Jigs and fixtures details
Equipment maintenance procedures
Validation reports for special processes and software, if
applicable

Sterilization specifications, procedures, and validation


reports, if applicable
assurance procedures and specifications (QA)

Quality agreement with Contract Manufacturer.

Quality system operational procedures (QOP), if


applicable
Quality system forms (QF), if applicable
Process control specifications/charts

Control plans, instructions and acceptance criteria for


incoming, in-process, and finished device inspection and
testing
Blank work order forms for recording inspection/testing
activities, traceability, and other data for device history
records

Device release review/OQC checklists

ackaging and labeling specifications (PL)

Package drawings, specifications, procedure and labelling


Product labels/labeling drawings

Instruction manuals

Storage requirements
n, maintenance and servicing specifications (IMS)

Installation, specifications and instructions


Maintenance instructions

Servicing specifications and manuals


pproved by

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