Biomedical Engineering Reference
In-Depth Information
Table 4.1: Précis of FDA Guidelines and ISO 13485
Row
Number
FDA Design
Control
Guidance
ISO 13485
Synopsis
Section
in This
Text
#1
FDA 21 CFR
820.30
Section 7 Product
Realization
The standards lay down the
requirements that all medical
device manufacturers design,
develop, and ensure continual
improvement of their devices.
4.3
#2
Section B
Design Planning
7.1 Planning of Product
Realization
All manufacturers of medical
devices must have procedures in
place to ensure that their devices
are designed and developed
correctly. All tasks should be
planned.
4.3
#3
Section C
Design Input
7.2.1 Determination of
requirements related to the
product
One of the main aspects of
control is to ensure that the
requirements and product
specifications are clearly
identified. Again, procedures to
ensure it is done correctly are
required.
4.3
#4
Section C
Design Input
7.2.2 Review of requirements
related to the product
See #3
4.3
#5
7.2.3 Customer
Communication
See #3
4.3
#6
Section B
Design Planning
7.3.1 Design and
Development Planning
See #2
4.3
#7
Section C
Design Input
7.3.2 Design and
Development Inputs
See #3
4.3
#8
Section D
Design Output
7.3.3 Design and
Development Outputs
All design outputs are reviewed
before release.
4.3
#9
Section E Design
Review
7.3.4 Design and
Development Review
Design processes(etc.) are
reviewed at planned and strategic
times.
4.4
#10
Section F Design
Verification
7.3.5 Design and
Development Verification
Checking that the design output
actually meets the requirements
stipulated in the design input!
4.5.3
4.4
#11
Section
G Design
Validation
7.3.6 Design and
Development Validation
Checking that the design output is
fit for its purpose within the field
of intended use. This may include
clinical evaluations or it may be
checking that a “large” device
works once installed.
4.5.3
#12
Section H
Design Transfer
4.2.4 Control of Records
A very general paragraph stating
the requirements to maintain
controlled records, and the
duration of retention.
4.5.5
( Continued )
 
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