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Quality
We
believe in quality being 'built-in' and have taken
great efforts with our design to ensure a sound technology base.
Rather than using commercial suppliers and a subsequent cleaning
process, we have ensured cleanliness by having all components manufactured
in cleanroom conditions, including cleanroom moulding.
All of our suppliers hold medical quality approvals.
Final sterilisation by Ethylene Oxide gives a very robust
confidence in sterility with low pre-sterilisation bio burdens.
We
are approved to ISO9001 and the more rigorous medical version
EN46001
/ ISO 13485. This enables
us to both design and manufacture single use surgical instruments.
We also have full batch traceability to emphasise the importance
of controls within
our suppliers and confidence in product integrity.
The
surgical suctions are also approved under Medical Device Directive
93/42/EEC. The quality system includes detailed technical files
giving risk assessments, FMEA's and specification details. The approval
allows use of the CE mark, showing compliance with all CE medical
standards and enabling their use in all EEC countries.
Finally our products
are also approved by
CMDCDS (Canada) FDA (USA) and by the Japanese
and Australian authorities.
We
were audited by SGS Yarsley - one of the leading medical auditors.
Their website has useful links to
several other medical standards and guidelines
(click here).
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l last update 09.11.2004
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