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    PD233 Lecture5 DesignDocumentation PDF

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    vignesh kumar
    The document discusses documentation requirements for medical devices as mandated by the FDA. It provides an overview of Title 21 of the Code of Federal Regulations (CFR), which defines requirements for both drugs and medical devices. The CFR is organized into different volumes covering general FDA regulations, foods, drugs, biologics, and medical devices. Key documentation that must be maintained for medical devices include the design history file, device master record, device history record, and technical documentation file. These records provide evidence of the design, manufacturing, and distribution processes for audit purposes.

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    PD233 Lecture5 DesignDocumentation PDF

    Uploaded by

    vignesh kumar
    128 views26 pages
    The document discusses documentation requirements for medical devices as mandated by the FDA. It provides an overview of Title 21 of the Code of Federal Regulations (CFR), which defines requirements for both drugs and medical devices. The CFR is organized into different volumes covering general FDA regulations, foods, drugs, biologics, and medical devices. Key documentation that must be maintained for medical devices include the design history file, device master record, device history record, and technical documentation file. These records provide evidence of the design, manufacturing, and distribution processes for audit purposes.

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    The document discusses documentation requirements for medical devices as mandated by the FDA. It provides an overview of Title 21 of the Code of Federal Regulations (CFR), which defines requirements for both drugs and medical devices. The CFR is organized into different volumes covering general FDA regulations, foods, drugs, biologics, and medical devices. Key documentation that must be maintained for medical devices include the design history file, device master record, device history record, and technical documentation file. These records provide evidence of the design, manufacturing, and distribution processes for audit purposes.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    128 views26 pages

    PD233 Lecture5 DesignDocumentation PDF

    Uploaded by

    vignesh kumar
    The document discusses documentation requirements for medical devices as mandated by the FDA. It provides an overview of Title 21 of the Code of Federal Regulations (CFR), which defines requirements for both drugs and medical devices. The CFR is organized into different volumes covering general FDA regulations, foods, drugs, biologics, and medical devices. Key documentation that must be maintained for medical devices include the design history file, device master record, device history record, and technical documentation file. These records provide evidence of the design, manufacturing, and distribution processes for audit purposes.

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    You are on page 1of 26

    PD233: Design of

    Biomedical Devices and


    Systems
    (Lecture-5 Design Documentation)

    Dr. Manish Arora


    CPDM, IISc
    Course Website:
    http://cpdm.iisc.ac.in/utsaah/courses/
    FDA CFR 21
    In United States the requirements of Documentation are
    mandated by Title 21 of Code of Federal Regulations
    (CFR) for both drugs and medical devices.
    • Volume 1: Parts 1–99 (FDA, General)
    • Volume 2: Parts 100–169 (FDA, Food for Human Consumption)
    • Volume 3: Parts 170–199 (FDA, Food for Human Consumption)
    • Volume 4: Parts 200–299 (FDA, Drugs: General)
    • Volume 5: Parts 300–499 (FDA, Drugs for Human Use)
    • Volume 6: Parts 500–599 (FDA, Animal Drugs, Feeds and Related Products)
    • Volume 7: Parts 600–799 (FDA, Biologics; Cosmetics)
    • Volume 8: Parts 800–1299 (FDA, Medical Devices)
    • Volume 9: Parts 1300–End (DEA and Office of National Drug Control Policy)

    for example
    21 CFR part 820: defines medical device quality system
    (QS) regulation;
    -Part M: of the act defines general and specific
    record-keeping requirements for medical devices.
    Documentation requirements
    • Maintained by manufacturer
    • Auditable by FDA or equivalent authority
    • They must be legible and stored so as to minimize
    deterioration and to prevent loss
    • Those stored digitally must be backed up and have
    a disaster plan in effect
    • Can be deemed as confidential
    • To be maintained for expected life time of the
    product (but not less than 2 year)
    Documents
    Information used to support an effective and efficient
    organizational operation.
    Documents are created as a part of your planning
    Need to be reviewed, updated and approved – i.e.
    document control.
    • Business proposal
    • Product specification
    • Design specification
    • Software quality assurance plan (SQAP) (where applicable)
    • Software requirements specification (SRS) (where applicable)
    • Software design description (SDD) (where applicable)
    Records
    Records are evidence of activities in past.
    Records are facts and should not change, new
    records can be added.
    Four types of records in context of medical devices:
    1. Design history file (DHF)
    2. Device master record (DMR)
    3. Device history record (DHR)
    4. Technical documentation file (TDF)
    Documents
    Business Proposal
    Purpose: to identify and document market needs, market
    potential, the proposed product and product
    alternatives, risks and unknowns, and potential financial
    benefits.
    The business proposal usually contains:
    • Project overview, objectives, major milestones, schedule
    • Market need and market potential
    • Product proposal
    • Strategic fit
    • Risk analysis and research plan
    • Economic analysis
    • Recommendation to form a core project team
    • Supporting documentation
    Product Specification
    • First step in realizing a product idea into a approved
    product development effort.
    • It specifies what the product will do, how it will do
    it, and how reliable it will be. To be effective, it
    must be as precise as possible.
    • The product specification should be a controlled
    document, i.e., subject to revision level control, so
    that any changes that arise are subjected to review
    and approval before implementation.
    Product Specifications
    The specification is a detailed review of the proposed product
    and includes
    • Type of product
    • Market it addresses
    • Technology to be used
    • Function of the product
    • Product parameters necessary to function effectively
    • Accuracy requirements
    • Tolerances necessary for function
    • Anticipated environment for the device
    • Cautions for anticipated misuse
    • Safety issues
    • Human factors issues
    • Anticipated life of the product
    • Reliability goal
    • Requirements from applicable domestic or international standards
    Product Specifications
    • Product specification are derived by agreement of
    multiple stakeholders: marketing, design engineering,
    manufacturing, customer service, reliability assurance,
    quality assurance, and regulatory affairs
    • Each requirement should be identified with some form
    of notation, such as brackets and a number.
    Example:
    5.3.1 Analog to Digital Converter
    The output of the analog to digital converter must be
    between X and Y [1].
    This requirement can be later referred to as 5.3.1-1
    Design Specifications
    • The design specification is a document, which is
    derived from the product specification.

    The requirements found in the product specification


    are partitioned and distilled down into specific
    design requirements for each subassembly.
    Design Specification
    The design specification should address the following areas for each
    subsystem:
    • Reliability budget
    • Service strategy
    • Manufacturing strategy
    • Hazard consideration
    • Environmental constraints
    • Safety
    • Cost budgets
    • Standards requirements
    • Size and packaging
    • Power budget
    • Heat generation budget
    • Industrial design/human factors
    • Controls/adjustments
    • Material compatibility
    Design Specifications
    All electrical and mechanical inputs and outputs and
    their corresponding limits under all operating modes
    must be defined.

    As in the product specification, the requirements in


    the design specification should be identified by a
    notation such as a bracket and numbers.
    Other Controlled Documents
    • Software quality assurance plan (SQAP)
    • Software requirements specification (SRS)
    • Software design description (SDD)

    Reference: Chapter 5, King & Fries, Design of


    Biomedical Devices and Systems
    Assignment 2
    Prepare 5-7 minute presentation for business case
    your proposed team project device.
    • Starting with market need and market potential your task is
    convince senior management of your organization that it is a
    product line getting into and your team is fit for doing the
    job (strategic fit).
    • All data sources should be referenced
    • Major milestones, schedule for you product/prototype
    development
    • Risk analysis for the project should also be presented
    Presentations on 6th September 2016 (10am)
    Project
    Allocations
    Records for Medical Device
    1. Design history file (DHF)
    2. Device master record (DMR)
    3. Device history record (DHR)
    4. Technical documentation file (TDF)
    Design history file (DHF)
    • DHF is a compilation of records, which describes the
    design history of a finished device.
    • It covers the design activities used to develop the
    device, accessories, major components, labeling,
    packaging, and production processes.
    • The DHF contains or references the records necessary
    to demonstrate that the design was developed in
    accordance with the approved design plans and the
    requirements of the quality system regulation.
    • CFR 21 820.30(j) requires that each manufacturer
    establish and maintain a DHF for each type of device.
    Design history file (DHF)
    The design plans and subsequent updates should be
    part of the DHF.
    In addition, the Quality System (QS) regulation
    specifically requires that
    • Results of a design review, including identification of
    the design, the date, and the individual(s) performing
    the review, shall be documented in the DHF.
    • Design verification shall confirm that the design output
    meets the design input requirements. The results of the
    design verification, including identification of the design,
    method(s), the date, and the individual(s) performing
    the verification, shall be documented in the DHF.
    Design history file (DHF)
    Typical documents that may be in, or referenced in, a DHF include
    • Design plans
    • Design review meeting information
    • Sketches
    • Drawings
    • Procedures
    • Photos
    • Engineering notebooks
    • Component qualification information
    • Biocompatibility (verification) protocols and data
    • Design review notes
    • Verification protocols and data for evaluating prototypes
    • Validation protocols and data for initial finished devices
    • Contractor/consultants information
    • Product Documentation
    • Parts of design output/DMR documents that show plans were followed
    • Parts of design output/DMR documents that show specifications were met
    Medical device design process as specified US- FDA
    requirements (source http://fda.gov)
    Design history file (DHF)
    • Manufacture of the device are beneficiary of DHF
    • When problems occur during redesign and for new
    designs, the DHF has the institutional memory of
    previous design activities
    • The DHF contains valuable verification and
    validation protocols that are not in DMR.
    Device master record (DMR)
    DMR is a compilation of those records containing the specifications and
    procedures for a finished device.

    DRM should include or refer to location of information about:


    • Device specifications including appropriate drawings, composition,
    formulation, component, specifications, and software specifications
    • Production process specifications including the appropriate equipment
    specifications, production methods, production procedures, and
    production environment specifications
    • Quality assurance procedures and specifications including acceptance
    criteria and the quality assurance equipment used
    • Packaging and labeling specifications, including methods and
    processed used
    • Installation, maintenance, and servicing procedures and methods
    Device history record (DHR)
    DHR is the actual production records for a particular
    device.
    It show the processes, tests, rework, etc. that the device
    went through.
    The DHR should include or refer to the location of the
    following information:
    • Dates of manufacture
    • Quantity manufactured
    • Quantity released for distribution
    • Acceptance records which demonstrate the device is
    manufactured in accordance with the DMR
    • Primary identification label and labeling used for each
    production unit
    • Any device identification and control numbers used
    Technical documentation file(TDF)
    TDF contains all the relevant design data by means of which the
    product can be demonstrated to satisfy the essential safety
    requirements.
    It must include:
    • General description of the product, including any planned variants.
    • Design drawings, methods of manufacture envisaged and diagrams of
    components, subassemblies, circuits, etc.
    • Descriptions and explanations necessary to understand the above
    mentioned drawings and diagrams and the operations of the product.
    • Results of the risk analysis and a list of applicable standards applied.
    • For products placed on the market in a sterile condition, a description
    of the method is used.
    • Results of the design calculations and of the inspections carried out.
    • Test reports and, where appropriate, clinical data.
    • Labels and instructions for use.
    Quiz
    DHF DMR DHR TDF

    Clinical Trial Information  

    Project Plans 
    Design Specification  
    Design Validation Plans 
    Product Specification  
    Sales order report 
    Shipping report 
    Risk analysis  
    Tooling specs 
    Installation Instructions 

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