Biomedical Engineering Reference
In-Depth Information
but this does not mean that smaller ones get no attention - lots of small useless projects cost
as much as one big useless one!
The final part records approval or rejection. A single project may go through this process
several times before finally being approved, so just throwing the form back is unhelpful.
Clearly, if rejected the reasons why should be given. Equally, if accepted the reasons why
should be given.
What happens next? If accepted the new product procedure or the design modification
procedure kicks in (see Chapter 4). If rejected a comment is made in the log and a copy of
the forms filed; originals plus comments are returned to the originator to decide whether to
do some more work or stop. It is often the comments from the panel/board that make this
decision for the originator.
5.3 The Product Design Specification (PDS)
Much has been said about the PDS, and as you will know it is thanks to Pugh (1990) that we
have this useful tool. In the end it is immaterial whether you call it a PDS or a specification;
just make sure the word “specification” appears for your regulatory trail.
While we are on the subject of regulations they are a very good starting point for your PDS.
The EC directive (93/42/EC), for example, contains an annex called Essential and General
Requirements; these are things that your device must meet to be classed as a medical
device. The FDA and other bodies have similar sections. You should have a copy of these in
hand and tick them off as you your PDS development progresses to ensure that all has been
covered. Another good tip is to cross-reference your PDS against these requirements; this is
easily done by numbering each item in your PDS and using this number as the basis for the
cross reference.
We demonstrated (Chapter 4) that it is this document that highlights all of your inputs. Firstly
I shall present the inputs in a logical manner to enable you to formulate a PDS; secondly
I will show you how to get the information to fill it with. The latter, I assure you, is much
harder than the former!
5.3.1 Essential Elements of a PDS
As you can imagine, to list the potential content of a full PDS would be both time-
consuming and fruitless. It is more commonplace, and more beneficial to both you and
me, to present the basic elements and let you complete it using your own specialism. I
have already presented some texts for you to refer to. Developing your PDS is where you
really do need to refer to the literature. Do not just rely on this chapter; not because I do not
know what I am doing but because I cannot possibly cover every eventuality in the medical
devices world.
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