This session provides detailed examples to demonstrate what objective evidence is important to generate and use during design control compliance but, more importantly, to develop and issue a beneficial design history file meeting the requirements in 21 CFR, Part 820.30 and ISO 13485:2016. Aside from the importance of design controls for compliance, Mr. Gagliardi demonstrates how this section of the QS regulation and the ISO standard can be facilitated as a leading edge business tool.
3. Design Controls
Begins
Concept &
Feasibility
Risk Analysis
Begins
Manufacturing
Design
Review
Design
Review
Design
Review
Require Pilot
Mfring.
Phase
Product
Release
User Needs Verification
Design Validation
Design
Changes
Begin
DHF Begins
Design History File
Marketplace
Post Production
Product
History
Outputs OutputsOutputs
Design
Plan
QRB
Design Processes
Transfer
Inputs
In Continuum
DMR & the
Medical
Device File
10. Design Controls
Begins
Concept &
Feasibility
Risk Analysis
Begins
Manufacturing
Design
Review
Design
Review
Design
Review
Require Pilot
Mfring.
Phase
Product
Release
User Needs Verification
Design Validation
Design
Changes
Begin
DHF Begins
Design History File
Marketplace
Post Production
Product
History
Outputs OutputsOutputs
Design
Plan
QRB
Design Processes
Transfer
Inputs
In Continuum
DMR & the
Medical
Device File
27. Design Controls
Begins
Concept &
Feasibility
Risk Analysis
Begins
Manufacturing
Design
Review
Design
Review
Design
Review
Require Pilot
Mfring.
Phase
Product
Release
User Needs Verification
Design Validation
Design
Changes
Begin
DHF Begins
Design History File
Marketplace
Post Production
Product
History
Outputs OutputsOutputs
Design
Plan
QRB
Design Processes
Transfer
Inputs
In Continuum
DMR & the
Medical
Device File
42. Design Controls
Begins
Concept &
Feasibility
Risk Analysis
Begins
Manufacturing
Design
Review
Design
Review
Design
Review
Require Pilot
Mfring.
Phase
Product
Release
User Needs Verification
Design Validation
Design
Changes
Begin
DHF Begins
Design History File
Marketplace
Post Production
Product
History
Outputs OutputsOutputs
Design
Plan
QRB
Design Processes
Transfer
Inputs
In Continuum
DMR & the
Medical
Device File
43. When is Design Input Established?
Design Inputs Approved
(User Needs) (Design Input)
Development
Begins
User
Needs
End
Research Development
71. Example: Simple Design Matrix
Patient Monitor
Discuss Design Validation
User Need Design Input Design Output Design Verification
Portable
Instrument
• Dimensions no greater than
18.0” x 13.0” x 7.5”
• Weight = less than 11.5 lbs
Housing Drawing #765-003
Monitor Specification #763-124
Measure the Housing
Weigh the parts and weigh the
entire instrument
• Can be carried with one
gloved or bare hand
Handle Assembly Drawing #59-02 Measure the handle size
Used in a USA MD’s
Office
Operates on US Standard
Electrical Voltage
Electrical Plug Specification #77
Transformer Specification # V89 Measure the Voltage output
110-volt AC (110V) or 220-volt
AC (220V)
79. Design Controls
Begins
Concept &
Feasibility
Risk Analysis
Begins
Manufacturing
Design
Review
Design
Review
Design
Review
Require Pilot
Mfring.
Phase
Product
Release
User Needs Verification
Design Validation
Design
Changes
Begin
DHF Begins
Design History File
Marketplace
Post Production
Product
History
Outputs OutputsOutputs
Design
Plan
QRB
Design Processes
Transfer
Inputs
In Continuum
DMR & the
Medical
Device File
124. Design Controls
Begins
Concept &
Feasibility
Risk Analysis
Begins
Manufacturing
Design
Review
Design
Review
Design
Review
Require Pilot
Mfring.
Phase
Product
Release
User Needs Verification
Design Validation
Design
Changes
Begin
DHF Begins
Design History File
Marketplace
Post Production
Product
History
Outputs OutputsOutputs
Design
Plan
QRB
Design Processes
Transfer
Inputs
In Continuum
DMR & the
Medical
Device File
142. Design Controls
Begins
Concept &
Feasibility
Risk Analysis
Begins
Manufacturing
Design
Review
Design
Review
Design
Review
Require Pilot
Mfring.
Phase
Product
Release
User Needs Verification
Design Validation
Design
Changes
Begin
DHF Begins
Design History File
Marketplace
Post Production
Product
History
Outputs OutputsOutputs
Design
Plan
QRB
Design Processes
Transfer
Inputs
In Continuum
DMR & the
Medical
Device File