ISO 13485 :2003, ISO 9001 :2000, CMDCAS, FDA, CE, TGA
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 standard and also 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 (Failure Mode and Effects Analysis) 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 the 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)
TRIALS & APPROVALS:
Our suctions and other products in the Single Use Surgical range are trialled in hospitals all over the UK and Ireland every week. We believe that the best way to convey the quality and design of our products is to put them in the hands of those that use them.
We provide free trials for all of our products, this may be in the form of a rep visiting the Theatre or sending samples from our Office in Barnsley.
Our suctions have been well received by many hospitals and among the many comments was praise for the user-friendly design and improved suction performance compared to reusable devices.
Don't Take Our Word For It,
Here What Our Customers Have Said...
"Excellent design, fits the hand well"
"Fits better on to suctions tubing than the reusable"
"Suction better than fine American pattern, not as bulky as Yankauer"
"Good finger access to side vent and correct angle of tube"