Transcript Product Documentation - Vanderbilt University

Product Documentation
Chapter 5
Rich Fries
Required Medical Device
Documentation
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Business proposal
Product specification
Design specification
Software Quality Assurance Plan
Software Requirements Specification
Software Design Description
Primary types of records
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Design History File (DHF)
Device Master Record (DMR)
Device History Record (DHR)
Technical Documentation File (TDF)
Business Proposal
• 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 Core Project Team
• Supporting documentation
Project Overview, Objectives, Major
Milestones, and Schedule
• Statement of overall project objectives and
major milestones
• Objectives clearly define project scope
and provide specific direction
• Schedule anticipates key decision points
and completion of primary deliverables
• Events contingent upon achievements of
estimated dates should be stated
Market Need/Potential
• Defines customer and clinical need for
product or service
• Identifies potential territories to be served
• Examines market size and trends
• Compare product with competitors
Product Proposal
• Proposes the product idea that fulfills the
market need
• Differentiates product features
• Explains user and/or clinical value
• Several alternatives product ideas should
be evaluated against ‘base case’ idea
Strategic Fit
• Discusses how the proposed product conforms
with (or departs from) stated technology with
respect to:
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Product
Market
Clinical setting
Technology
Design
Manufacturing
Service
Risk Analysis and Research Plan
• Assessment of risks and unknowns
• Estimate of resources needed to reduce risks to
a level with a reasonably high level of
confidence
• Risk categories:
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Technical
Market
Financial
Regulatory
Available resources
Schedule
Economic Analysis
• Rough estimate of costs and personnel
required to specify, design, develop, and
launch each product variant into the
market place
Core Project Team
• Formation of core project team to perform
research to reduce risks, develop user
specification, and prepare project plan
• Outline requisite skills of proposed team
members
• Estimate approximate time required of
each participant
• Estimate incremental expenses
Product Specification
• First step in transforming product ideas
into approved product development efforts
• Subject to revision level control
• Joint ownership among all concerned
departments
Design Specification
• Derived from product specification
• Addresses each subsystem
• Each performance specification should be
listed with nominal worst case
requirements
Software Quality Assurance Plan
(SQAP)
• Assures that procedures, tools and
techniques used during software
development and modification are
adequate to provide desired level of
confidence in final product
• Assures that software does not reduce
reliability of device
Software Requirements
Specification (SRS)
• Specification for a particular software
product or programs that perform certain
functions
• Correctly defines software requirements
• Each software requirement is a statement
of some essential capability of the
software to be developed
Software Design Description (SDD)
• Specifies necessary information content
and recommended organization for a
software design description
• Detailed blueprint for implementation
activity
• Each requirement must be traceable to
one or more design entities
Design History File (DHF)
• Compilation of records which describes the
design history of a finished device
• Contains or references the records necessary to
prove that the design was developed in
accordance with approved design plans
• Contains ‘institutional’ memory of previous
design activities
• Contains verification and validation protocols
Technical Documentation File
(TDF)
• Contains relevant design data which
demonstrates that essential safety
requirements are satisfied
• File must be kept for 10 years after
production stops in case of liability
proceedings
• Allows assessment of the conformity of the
product with requirements of the Medical
Device Directives