After two years of work, Pierhor-Gasser has received ISO 13485 certification. This recognition means the company can now meet the demands of medical device companies.
Pierhor-Gasser’s unique expertise in synthetic single-crystal machining, such as ruby, sapphire and spinel, has attracted the attention of major medical equipment companies, particularly for the company’s ruby insulators used in pacemakers. “We have been contacted by the world leader, an American company, that is very interested in our expertise in synthetic single-crystal stone machining,” explains Jean-Michel Uhl, CEO of Pierhor-Gasser.
Faced with the demands and requirements of the medical device industry, Pierhor-Gasser worked for two years to obtain ISO 13485 certification, and this was achieved at the beginning of January 2021.
“This is a great satisfaction for our teams,” says Jean-Michel Uhl. “Just over a year after receiving ISO 9001, we have now taken another step towards guaranteeing our customers the high-quality management standards and safety management systems for our medical device components.”
Pierhor-Gasser is one of the first Swiss manufacturers of synthetic stones to obtain this certification. This is an important competitive advantage that guarantees compliance with regulatory requirements, control of special processes, risk analysis during product development and traceability of each medical device component that we supply.
Mixture of “counter-pivots” used as a stop, and a “support stone” used as a sliding bearing.
The blue parts are made of spinel, the red ones of ruby and the transparent ones of sapphire.
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