Implementing Design Procedures - Medical Device Design: Innovation from Concept to Market - page 54

4.2 Review of Guidelines
Table 4.1 provides a précis of the “design” sections of the FDA guidelines (FDA,1997) and
ISO 13485 (ISO,2003) and the ISO 9000 family (ISO,2007).

You should now see that the guidelines all point in the same direction. Your processes must
meet the issues presented in Table 4.1 , demonstrably . The most common and most acceptable
way to do this is to have documented procedures. How these are presented is your preference.
It is perfectly acceptable to have written procedures; equally, it is just as acceptable to have
flowchart -based procedures. You need to decide which form best fits your aspirations. The
following sections will not prescribe which method to use but are intended to give you some
ideas on how to formulate your procedures.

4.3 Overall Procedure
To fulfill the requirements for FDA Section B and its ISO equivalents you will need to
formulate an overall design and development procedure. This procedure maps the route from
input to output and how these interact with your company's other procedures (procurement
for example). Figure 4.1 illustrates a typical flowchart for an overall design procedure.

INPUT

Postmarket surveillance

Research and development

Develop a need

Customer demand

Preventative action

Yes

No

New product? New product procedure

Complaints/vigilance

No

Approved Call a halt?

No

Yes

No

Yes

Don't go ahead Design change Design change procedure

Design file completion

Device release

OUTPUT

Yes

To Quality Mgt Review: What went wrong?

Figure 4.1
A typical input-related design procedure.