Evaluation (Validation and Verification) - Medical Device Design: Innovation from Concept to Market - page 202

section states what your device has to be measured against before it can be accepted for use.
If your PDS has been written properly then planning your clinical evaluation is easy.
9.1.5 Method of Demonstration
In all cases this entails the production of an evaluation report. I will try and make this
description viable for both the USA and EC regulations. In essence the only real difference
between the two systems is the wording; all will become clear. The report will need to contain
specific sections, as described subsequently. The following sections of this chapter do not
necessarily map to any particular section of a 510(k) application or an EC technical file as
they are all applicable to all sections. You need to decide which evaluation tool is best to
measure your particular outcome.
9.2 Risk Analysis
This is the “Daddy” of them all. It is the precursor to all that follows. In essence a clinical
evaluation follows an overall risk analysis - however in practical terms they are so
interlinked that it is impossible to separate them. Hence I am introducing risk analysis as a
tool to be used in your overall evaluation of your device. In fact, an overall risk analysis is
essential for all medical devices, in the USA or in the EC. So this is the right time to think
about it.
Unlike many other disciplines we do not have any choice about risk analysis; we must use the
ISO standard “BS EN ISO 14971:2009: Medical devices. Application of risk management to
medical devices” ( BSI, 2009 ). The first (and largest) portion of the document concerns risk
management. You must have a risk management procedure, and this standard actually gives it
to you - so there can be no mistake. A subsection concerns risk assessment; again this process
is almost handed to you. The only thing you can change is how you present your findings; all
else is legislated. Avoid using this standard at your peril. Indeed if you avoid it in the EC you
will lose your CE mark and your right to be a medical device manufacturer; do not think the
FDA will be any less stringent!
The important thing to consider with risk analysis is the simple scientific principle of cause
and effect. In risk analysis we do this backwards; we think of the effect(s) and then determine
the root causes(s). However, unlike the design FMEA presented earlier we are only asked to
consider effects that can harm a patient, an end-user, or a bystander. Any embarrassment to
the company is a secondary issue, if that. Thus we imagine horrible things that could happen
as a result of your device being used and then determine the associated risk. But we do need
to start thinking of “nasty things” that can happen.
The essence of ISO 14971 is that you must have a risk management procedure in place. It is
a nice standard. It not only gives you the procedure (so there is no need to develop your own,
all you need do is make it work for your company), it gives you sample risk analysis forms