Biomedical Engineering Reference
In-Depth Information
14.5.6 Advice
For the first time “medical devicee” there is little to suggest apart from seek advice.
Unfortunately no number of short courses makes up for the experience of being audited. Seek
out similar companies to yours and ask advice. Find a good consultant to walk you through
the process: do not let them write everything for you but get them to help you write your own.
Also, ask them to be with you during the audit process. This simple request will repay itself
very quickly.
14.5.7 The Outcome
After your audit do not be surprised to get comments and suggestions for improvement.
These will come as minor or major nonconformities. Normally a minor nonconformity
is something small and non-life threatening, hence the need for a rapid response is
not demanding. A major nonconformity, however, can lead to no CE mark: this means
something serious is wrong and needs to be put right. It does not mean you have failed,
it just means there is something wrong; you should treat all nonconformances as
learning opportunities (remember from the ashes of disaster…). We have all seen major
nonconformances in our time, and we have all had to deal with them; but we have all
improved our processes as a result.
You will need to agree on a scope with your auditor. The scope is what appears on your
certificate so if you sell x-ray machines a scope of kidney dishes is useless. Equally do not
be so proscriptive that it leaves you with no room for diversity: do not have one saying 6 mm
bone screws instead of simply bone screws.
At some stage, hopefully immediately after the audit, you will receive confirmation that you
have been successful and you will be assigned the relevant certificate. This is not the end;
it is commonplace for the notified body to request electronic copies of the technical files
(normally one per year) for inspection. Furthermore, just like the FDA, this is an annual
process and you must expect to go through it again 12 months later.
14.6 Getting to Market
Unfortunately obtaining the 510(k) and the CE mark does not, in itself, guarantee sales.
It only gives us the ability to sell . There is no doubt that the medical devices market is the
most lucrative of markets; but it is also, without doubt, the hardest to penetrate. It is beyond
the scope of this text to start you on a marketing strategy course but it is pertinent to look at
how the design process has helped.
14.6.1 Unique Selling Points (USP)
All sales staff like an identifiable USP. What makes your device stand out from the crowd?
Your PDS should have identified improvements or design differences. The most commonly
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