Joe Selva
Rohan Thakkar
Jean Valderrama
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“Documentation” is what’s written on paper
Provides written details, events, and
information about a particular process.
Using documentary evidence to confirm that a
fact or statement is true.
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Can include, but not limited to:
Operator manuals
 Instruction sheets
 Online help systems
 Maintenance manuals
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Communication should be maintained
throughout the documentation process
Clear writing, complete information, and good
organization are, of course, key to the success
of any design document.
If it isn’t documented, it didn’t happen!
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Creates paper trail tracing design
documentation
Maintains proof of design process
Meets governing body requirements
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Everything throughout the process!
Meetings: date, length, attendance, purpose, and
outcomes.
 Ideas: thoughts and sketches
 Prints: models, computer generated drawings (CAD,
Solidworks, etc.), and tolerance stack-ups
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Phone calls: date, time, and purpose.
Reference to other manuals: manufacturing
processes and material manuals.
Emails sent back and forth throughout
Testing: standards, calibration of equipment, where
the test happens, materials used, etc.
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Notebooks
Preliminary sketches
 Meeting discussions
 Concept development and ideas
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Email Messages
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Discussion on design development, with all parties
involved (i.e. professors, physicians, engineers, team
members, etc.)
File Folders
Binders
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Computerized Copies
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Microsoft Office Files (Word, Excel, etc.)
Forms specific per company
Forms provided by the FDA or other
organizations to regulate products
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Business Proposal
Product Specifications
Design Specification
Software Quality Assurance Plan (SQAP), where applicable
Software Requirements Specifications (SRS), where applicable
Software Design Description (SDD), where applicable
Design History File (DHF)
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Design Input
Design Output
Design Review
Verification and Validation
Device Master Record (DMR)
Device History Record (DHR)
Design Transfer
Design Change
Technical Documentation File (TDF)
FDA Required Documents
An Executive Summary introducing what will be
provided to the customer and how they will benefit
from it.
 Product Overview, Objectives, Major Milestones,
Schedule
 Market need and market potential
 Product proposal
 Strategic fit
 Risk analysis
 Economic analysis
 Supporting documentation
Statement of what a not-yet-designed product is
intended to do. To ensure that the subsequent
design and development of a product meets the
needs of the user.
 Type of product
 Market it addresses
 Function of the product
 Accuracy requirements
 Safety issues
 Reliability goal
Provides explicit information on the requirements
for a product and how the product is put
together.
 Manufacturing strategy
 Safety
 Cost budgets
 Size and packaging
 Standards requirements
 Environmental constraints
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The purpose of (SQAP) is to define the techniques,
procedures, and methodologies that will use to
assure timely delivery of the software that meets
specified requirements of the project.
Develops and documents the software
development, evaluation and acceptance
standards.
Assures that the results of software quality reviews
and audits will be given to appropriate
management department.
Assures that test results adhere to acceptance
standards.
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SRS is a complete description of the system to
be developed.
It describes all the interactions the users will
have with the software.
In addition, the SRS also contains nonfunctional requirements which impose
constraints on the design or implementation.
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Such as: Quality Standards
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An SDD is a representation of a software
design that is to be used for recording design
information addressing various design
concerns and communicating that information
to the design’s stakeholders
This includes traditional software construction
activities, when design leads to code, and
“reverse engineering” situations where a
design description is to be recovered from an
existing implementation.
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Compiles records describing the design history of a
finished device
Complies with FDA requirements for marketing
medical device
FDA Requirement:
“Each manufacturer shall establish and maintain a DHF
for each type of device. The Device shall contain or
reference the records necessary to demonstrate that the
design was developed in accordance with the approval
design plan and the requirements of this part.”
Code of Federal Regulations, Title 21 – Food and Drugs, Chapter I – Food and Drug Administration Department of Health and Human Services, Subchapter H – Medical Devices.
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Specific to each company
Design review meeting information
Design plans
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Inputs and Outputs
Sketches
Drawings
Photos
Emails
Notebooks
Biocompatibility
Reviews
Verification and validations
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Test procedures
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Functional Requirements
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Performance Requirements
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Strength and durability
Product longevity
Sterilization
Packaging/Labeling requirements
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All functions the final product must perform
Is special packaging needed for this device?
Human factors
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Immune response to foreign body
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Results of design and engineering.
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How are they documented?
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Specifications of the final device- Manufacturing
process, measurement or test methods
Models, drawings, engineering analysis and other
documents
Output must be traceable to input requirement.
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Formal review of device
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Conducted by representatives involved in design
effort and any other interested parties (e.g. sales,
marketing, manufacturing engineering).
Documented in DHF
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Date, participants, design version reviewed, results
of review
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Verifies the output conforms to design input.
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Validated using initial/low production process.
Making sure the device works using normal
production process rather than using prototype
processes
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Tests, inspections, analyses.
Can the workers of the manufacturing company produce
multiple functional prototypes?
Documented in DHF
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Verification date, participants, design version reviewed,
and review results.
Routine documentation required to manufacture devices that
meet the company requirements.
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Contents
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Device Specification
• Drawings, composition, formulation, component specifications, and
software applications
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Product Process Specifications
 Equipment specifications, production methods and procedures, and
production environment specifications
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Quality Assurance Procedures and Specifications
 Quality Assurance- determining whether or not a product/ service
meets the customers expectations.
• Design, development, production and service of product are considered
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Packing and Labeling Specifications
Installation, Maintenance, and Service Procedures and Methods
Shows all operations, processes, etc. described in the
DMR have been accomplished for the finished device
and also includes:
 Date(s) of manufacturing
 Quantity Manufactured
 Quantity released for distribution
 Any device identification and control number(s)
 Primary identification label
 Labeling used for each production unit
 Acceptance records which demonstrate the device
is manufactured in accordance with DMR.
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Device History File- how you developed the
recipe for making your device
Device Master Record- the recipe for making
the device
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Specifications, work instructions, inspection
procedures.
Device History Record-The “batch” or lot of
devices was made according to the recipe.
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Transfer of product from design engineering to
manufacturing.
Includes detailed production specifications
Detailed product drawings, workmanship standards,
manufacturing instructions, inspection criteria, heat treat
conditions, etc.
 Some components might be purchased elsewhere,
integrates them in the process.
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Increases efficiency and quality of production
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Communicates and documents changes
throughout design process
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Shows date and time when revisions occurr
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Traces development of new product
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Approved and signed off on by appropriate
departments during development
Contains all relevant design data which the product can be demonstrated to
satisfy the essential safety requirements which are formulated in the Medical
Device Directives.
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Medical Device Directives- Regulations set forth to legally place a medical device on
the European market
General description of the product, including any planned variants
Design drawings, methods of manufacturing envisaged and diagrams of
components, sub-assemblies, 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 in
full or in part, and descriptions of the solutions adopted.
In the case of products placed on the market in a sterile condition, a
description of the methods used
Test reports and, where appropriate, clinical data
Labels and instructions for use
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Document that tries to foresee possible risks
and provides response plans to avoid the
impact of reoccurring errors.
Design Failure Mode Effects Analysis
(DFMEA)
Process Failure Mode Effects Analysis
(PFMEA)
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Medical Device Definition
Device Classification
510k
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Design and development plans
Design reviews
Design verification
Validation testing and results
Product specification
Premarket Approval (PMA)
Good Manufacturing Compliance (GMP)
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Assume everything you hear, say, think, write,
read, and create is important no matter how
insignificant, trivial, irrelevant, or
inconsequential you might think it may be.
Record, date, sign, and save everything
throughout the devices design.
FDA will come in to audit all information for
approval.