Joel Gerber
Zachary Reaver
Kurt Schilling
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Provides physical proof of development
Maintains product design knowledge base
Meets government and corporate
requirements
Communicates design planning and
implementation
Enables smooth project transitions
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Collaboration
◦ Meeting minutes
◦ Phone calls
◦ E-mails
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Technical
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Preliminary design sketches
Calculations
Tolerance stack-ups
Testing records
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Date and time
Parties present
Discussion summary
Action items
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Drawings
Design Changes
Design and Process Validations/Verifications
Risk Management Documentation
Process Routers
Inspection Criteria
Design Control Plans
Material Specifications
Sterility and Cleaning Process Verifications
Tolerance Stack-ups
Device Master Record (DMR)
FDA Submissions
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Engineering Notebooks
◦ Preliminary sketches
◦ Meeting notes
◦ Concept ideas and development
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Microsoft Word and Excel documents
◦ Engineering Analysis
◦ Summaries
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E-mail messages
◦ Design discussions
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Compiles records describing the design history of a
finished device
Complies with FDA requirements for marketing
medical device
Specific to each company
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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Items can include:
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User Needs
Design Inputs
Design Outputs
Design review meeting information
Design Verification
Design Validation
Design Transfer
Design Changes
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Outlines the activities to be taken during the
design control process
Sets target dates for finishing each stage of
development, as well as design reviews
◦ Gantt Chart
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Identifies team members from each necessary
department
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Customer Requirements
Defines the use for the product in the market
Drives the development process
Typically gathered by marketing team
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Translate customer’s needs into design
Reduce miscommunication between
engineering and marketing teams if used
effectively
Improve efficiency of the design process
Require documentation and approval
Define performance and function
requirements
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Functional requirements
◦ Lists all functions the final product must perform
◦ Lists compatibilities with mating parts
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Performance requirements
◦ Benchmarks the final product must meet
◦ Include strength, durability, and lifespan
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Sterilization Method
◦ Defines how product will be cleaned
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Packaging/Labeling requirements
◦ Defines specifications that labeling/packaging must
meet
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Human Factors
◦ Specialized inputs to define how people interact
with a medical device
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Bring design inputs to life
Outline what happened in design process
Items include:
◦ Product specifications, drawings, packaging,
labeling, instructions for use, design rationale
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Evaluates all risks of product and production
process
Identifies actions to manage unacceptable
design and process risks
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Design Failure Mode Effects Analysis (DFMEA)
Process Failure Mode Effects Analysis (PFMEA)
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Potential product failures
Effects of product failures
Causes of failures
Corrections of failures
FMEA Example: Toothbrush
Other Examples:
•Predicate Device
•Testing Standards
•Clinical History
•Engineering Analysis
•Surgical Technique
•Intra-op feedback
•Design Controls
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Identifies and evaluates design at several stages
of the development process (Design Review I, II,
III, etc.)
Each review has a series of checklists and criteria
that must be met
Utilizes knowledge base of multi-function team
representatives concerned with the design stage
Approved by multiple departments in order to
proceed with development
◦ Packaging, Labeling, Product Development, Quality,
Regulatory, etc.
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Communicates and documents changes
Creates links between revisions
Traces development of new product
Approved by appropriate departments during
development
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Validation – “Are you building the right
thing?”
◦ Make sure product meets user needs
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Verification – “Are you building it right?”
◦ Ensure that final product meets initial design
specifications
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Ensures that outputs conform to inputs
Consists of tests, inspections, and analyses
Requires documentation of acceptance
criteria and protocols
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Compilation of records containing the
specifications and procedures for a finished
device
The DMR for each device should include or
refer to the location of:
◦ Device specifications including appropriate
drawings, composition, formulation, component
specifications, and software applications
◦ Production process specifications including
appropriate equipment specifications, production
methods, production procedures, and production
environment specifications
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Other items include:
◦ Quality assurance procedures and specifications
including acceptance criteria and the quality
assurance equipment used
◦ Packaging and labeling specifications, including
methods and process used
◦ Installation, maintenance, and service procedures
and methods
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Facilitates transfer of product from design
engineering to manufacturing engineering
Includes detailed production specifications
Increases efficiency and quality of production
• http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRe
quirements/QualitySystemsRegulations/MedicalDeviceQualitySystemsManual/ucm
122416.htm
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Assume everything you hear, say, think,
write, read, and create is important no matter
how insignificant, trivial, irrelevant,
immaterial, or inconsequential you might
think it may be
Record, date, sign, and save everything
Document as though an audit will occur
Include timestamps and revision numbers on
all documents