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.
 Quality system  Clarify requirements for
requirements: design, qualifying, verifying, and
purchasing, and validating processes
servicing controls and specification
 Clarify record keeping changes
requirements for device  Clarify requirements for
failure and complaint evaluating quality data
investigations and correcting quality
problems
 Design Controls
 Lack of = Major cause of device recalls
 Intrinsic quality established during design
phase
 FDA concerned that current regulations
don’t 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 manufacturer’s 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