Medical Design Briefs - March 2022 - 11

DESIGN V&V
Design validation and verification
are established and defined in the
Quality System Regulation 21 CFR
820.30. Each manufacturer of any
Class III or Class II device and
certain Class I devices must
establish and maintain procedures to
control the design of the device in
order to ensure that specified design
requirements are met.
Design Verification. Each
manufacturer shall establish and
maintain procedures for verifying the
device design. Design verification shall
confirm that the design output meets
the design input requirements. The
results of the design verification,
including identification of the design,
method(s), the date, and the
individual(s) performing the
verification, shall be documented in
the design history file.
Design Validation. Each
manufacturer shall establish and
maintain procedures for validating the
device design. Design validation shall
be performed under defined operating
conditions on initial production units,
lots, or batches, or their equivalents.
Design validation shall ensure that
devices conform to defined user
needs and intended uses and shall
include testing of production units
under actual or simulated use
conditions. Design validation shall
include software validation and risk
analysis, where appropriate. The
results of the design validation,
including identification of the design,
method(s), the date, and the
individual(s) performing the validation,
shall be documented in the design
history file.
Source: FDA 21 CFR 820.30
led to bridge tooling and automation,
quality control testing, and high-volume
fully automated production. The diabetes
device manufacturer achieved the desired
launch date and quality expectations,
delivering to market a device that will positively
impact patients' lives.
Conclusion
With the demand for the rapid manufacturing
of medical device components
at a lower cost, it is critical for device
manufacturers to partner with suppliers
that have rapid development capabilities.
Since RDCs often have a dedicated
team of veteran engineering, process,
and materials experts, they are often
able to take device development ideas
from design to serial production.
The process all starts by partnering at
the design stage and consulting with the
supplier's RDC team to create a product
that provides the best quality and patient
outcomes.
This article was written by Chris Tellers,
Rapid Development Center Director, Trelleborg
Healthcare & Medical, Fort Wayne, IN. For
more information, visit http://info.hotims.
com/82319-340.
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Medical Design Briefs, March 2022
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Medical Design Briefs - March 2022

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