Implementing Design Procedures - Medical Device Design: Innovation from Concept to Market - page 57

Table 4.1: Précis of FDA Guidelines and ISO 13485 (Continued) Table 4.1: Précis of FDA Guidelines and ISO 13485

Row
Number

FDA Design
Control
Guidance

ISO 13485 Synopsis Section

in This
Text

#13 Section I Design

Changes

7.3.7 Control of Design and
Development Changes

As designs progress things
change; there is a requirement
to keep track of changes and
the reasons for change. There is
also a requirement to keep “old
documents” (see 4.2.4).

4.5.4

#14 Section J Design

History File

4.2.3 & 4.2.4 Control of
Records

As per 4.2.4 but specific to the
design. A clear record of a design
and clear up-to-date description
of the design (for manufacture,
etc.) must be kept.

4.3
4.5.5

needs some further work, or (and this is by far the worst outcome) it is called to a halt and
abandoned. In both cases the reasons why it has failed (the root cause ) should be investigated
and fully documented/reported so as to inform others. The failure could be highly laudable, but
it could be something inherently wrong in your processes. You and your company should build
a strategy of learning from “failures”: “from the ashes of disaster grow the roses of success.” 1

4.4 Audit /Review Procedure
Two important aspects are hiding within the design review requirements. The first is the need
to undertake planned design activities and hence formal reviews of the design process are
required, e.g., weekly project meetings (we will address this in more detail later in this topic).
However the one thing most people forget is the requirement to actually ensure the design
process is working and that procedures are being followed and documented. We will look at
the former in later sections; for now we will examine the review process in more detail.

The reason for concentrating on this is that a medical device company need not be ISO
13485 or ISO 9000 certified to actually be a medical device company. It is not a statutory
requirement (except in Canada). A non-ISO registered company will not have a sense of the
importance of having this review procedure in place. But this does not mean that because they
don't that they are exempt - far from it; it is very important to set all procedures and put them
into motion. Hence, even if you are not ISO 13485 registered you should still try to work to
ISO 13485 standards - it is not a great challenge.

One example of an important procedure is one that ensures that a review of the design
process, activities, and outputs happens on a regular basis. All quality systems have an

1 From the film Chitty Chitty Bang Bang .