Implementing Design Procedures - Medical Device Design: Innovation from Concept to Market - page 67

Need from Fig 4.1

Appoint lead

Review DHF: ensure it is up-to-date
and complete.
Ensure all approvals are signed off

Open existing
Design History File
(Design File)

Clarification

Product specification

no yes

Conceptual
design

Detailed
design

Evaluation Release

Approved?

no

Embodiment Prototype Prototype Approved?

yes

yes yes yes

Fully document change

Approved? Approved? Approved?

Old documents in
repository

no no no

Decide where feedback applies

Figure 4.7
Design change procedure.

It should come as no surprise that a design change is similar to a full new product design.
There are, however, two main differences. The first is that this procedure will always
relate to an existing design file, hence the first step is to open an existing file. What
follows is the same. All that has been described before still applies. More often than not,
it is a small change that causes a company a lot of grief. So do not fall into the trap of
thinking that this procedure is only about documentation - it is about making a change
properly. Hence, having adopted the change, make sure you assess the risks associated
with said change. Finally, the end of the procedure is different; here one ensures that the
change (or changes) is fully documented in the file and the old documents are stored in a
repository ( Figure 4.7 ).

It is important to note that some design changes can be monitored internally; for others you
will be obliged to inform the regulatory bodies. We will be looking at this in more detail later.