Obtaining Regulatory Approval to Market - Medical Device Design: Innovation from Concept to Market - page 317

experienced medical devices auditor, you get an advisor as soon as possible and let them
“hold your hand” through the whole process. The initial costs may hurt, but the savings they
will make in the long run will pay you back many times over.
14.5.2 Documentation
ISO 13485 is a quality standard, so do not be surprised if you are asked to produce your
quality manual and procedures. Even if you only go for the CE certificate alone you will
still require these. You may be only CE marking the design of a device, but the auditors
will still want to audit the whole process from design to manufacture; from buying stock
to making individual lots; from writing the IFU to translating it into German; from sales to
postmarket surveillance; from complaint to vigilance. Once again obtaining good advice at
the start will help.
How you lay out your documentation is down to your own corporate systems, but some you
cannot avoid; here are a few to consider.
14.5.3 Technical Files (DHF)
It is with a high degree of certainty that I predict that your device's technical files will be
examined. Do not expect them to query your design - they will check that you have followed
your design procedures. They will check things such as inputs, risk analysis, design changes,
and the clinical evaluation report. In general the auditors will not be interested in the technical
files of Class I, but do not let this fool you - they could ask for one to see if you are really
applying your design procedures across the board.
14.5.4 Standards
You should have a register of standards and regulatory documents. All should be up to date
and your process should demonstrate that they have been audited for relevance and status at
least annually. Most certainly you should have copies of the MDD (all versions), ISO 13485
and ISO 14971 at hand. Also, do not forget the new Clinical Evaluation for Medical Devices
standard and all others that you refer to in your documentation.
14.5.5 Stock Control
You must have a stock control procedure in place. You must have complete traceability of all
your devices. If someone rings you to ask for the material specifications and source for Lot
No. 1245X you must be able to find this information. Equally, if your material supplier says
you need to find all components made from their Lot v345 you must be able to do so. The
auditors will check this with rigor.