Implementing Design Procedures - Medical Device Design: Innovation from Concept to Market - page 53

CHAPTER 4
Implementing Design Procedures
4.1 Introduction
This has been the hardest chapter to write. Procedures are very personal; there is not one
that is ideal for everyone. While I have attempted to present them in a logical order, the
placement of this chapter has been problematic. Which subject does one need to understand
first - the how or the why? There is no good answer. Hence I have decided to first show
you why procedures are important. But be aware that your procedures cannot be designed
and implemented until you fully understand the whole design process and all it entails,
i.e., everything that's contained in the rest of this topic. I apologize if this chapter seems
juxtaposed because of this, but bear with me and all will be right in the end.
The previous three chapters presented design to you as an idea and as a concept. In particular
Chapter 3 illustrated the basic concept of applying an engineering design model to satisfy
the regulatory requirements laid down by the regulatory bodies. However, as we found out,
the models and the regulations do not tell you how to actually do it. The subsequent chapters
will cover the implementation of the design models we have already met. This chapter,
however, covers the starting point for all regulatory implementations and makes sure that you
can demonstrate that you meet the regulations. The best way to do this, and in fact the only
accepted way, is to lie down and follow procedures. Hence this chapter will use the FDA
guidelines and ISO 13485 (and the ISO 9000 family) as the basis for the procedures. You
cannot go further unless you have copies of these in hand.
Remember that the medical device regulations demand one thing - to undertake your design
activities correctly. The aim of the procedures is to ensure that the word “your” in the previous
sentence is not just “you” but everyone with any design influence on the device. In other
words, going back to the definitions in Chapter 1, everyone associated with the manufacturer .
Although this chapter attempts to present procedures and how to implement them, it does not
present how your procedures should look. Procedures are as individual as you are - they need
to work for you. Hence this chapter describes what they should contain and how to design
them to it your needs. It does give examples, but by no means are these “gold standards” and
they should not be treated as such. Rather, use this chapter as a stimulus for you to begin to
think how your company functions and how to make it function better - that, after all, is what
a quality system is all about!