Chapter 19

Manufacturing and
Quality
Control
Design
of Biomedical
Devices and
Systems
By
Paul H. King
Richard C. Fries

GMP: History
Good Manufacturing Practices - Series of

requirements that prescribed the facilities,

methods, and controls to be used in
manufacturing, packaging, and storage of
medical devices
Medical Device Amendments of 1976
Unchanged since 1978

Current Good Manufacturing

Practice (CGMP)
Assure medical devices are compatible with specifications for
quality systems contained in international quality standard ISO
9001.
Clarify requirements for
Quality system
qualifying, verifying, and
requirements: design,
validating processes
purchasing, and
and specification
servicing controls
changes
Clarify record keeping
requirements for device Clarify requirements for
evaluating quality data
failure and complaint
and correcting quality
investigations
problems

Design Controls
Lack of = Major cause of device recalls
Intrinsic quality established during design

phase
FDA concerned that current regulations
dont provide an appropriate level of
assurance

Purchasing controls

Unacceptable components = recalls due to

device failures
Unacceptable components due to failure of
manufacturer to adequately define and establish
requirements
Purchasing of components, finished devices,
packaging, labeling, and manufacturing materials
must be conducted with same level of planning,
control, and verification as internal activities

Servicing Controls
Maintenance and repair data provide

insight into adequacy of the performance

of the device
Use to evaluate and monitor adequacy of
device design, quality system, and
manufacturing process
Use as part of overall device experience
data in manufacturers quality system

Design for Manufacturability (DFM)

Assures that a design can be repeatedly

manufactured while satisfying the

requirements for quality, reliability,
performance, availability, and price.
Less costly due to

Simpler design with fewer parts

Simple production processes
Higher quality and reliability
Easier to service

DFM Process
Eliminate nonfunctional parts
Reduce functional parts
Process for a defect rate of no more than

a few parts per million

Design for Assembly (DFA)

Overall Design Concept
Component Mounting
Test Points
Stress Levels and Tolerances
Printed Circuit Boards
Miscellaneous

Manufacturing Process
Pre-production activity
Pilot run build
Production run
Delivery to customer

Pre-Production Activity
Selection of Suppliers
Develop Pilot Run plan
Develop Manufacturing Strategy

Production plan
Quality plan
Test plan
Materials plan
Supplier plan

Pilot Run Build

Validate manufacturing process against objectives set

forth in manufacturing strategy and product
specification
Standard cost
Product quality
Documentation
Tooling
Training
Process control
Validates supplier plan and contracts
Internal failure analysis and corrective action

Production Run
Produce high quality product on time,

while continuing to fine tune the process

1st order manufactured
Verification of Product cost

Customer Delivery
Deliver 1st

production units to customer

Refine manufacturing process based on
first build
Monitor field unit performance to correct
any problems