Pierhor-Gasser obtains ISO 13485 certification

After two years of hard work, Pierhor-Gasser— the Vaud-based company and member of the Acrotec Group—has just received its ISO 13485 certification. This recognition means the company will now be able to deal with requests from medical device companies.

 

This in-depth knowledge has attracted the attention of major medical equipment companies, particularly regarding ruby insulators used in pacemakers. “Notably, we were contacted by a world-leading American company who was interested in this mastery of synthetic monocrystalline stone machining,” explains Jean-Michel Uhl, CEO of Pierhor-Gasser.

 

Because of these demands and the medical device industry’s requirements, Pierhor-Gasser worked for two years to acquire the ISO 13485 certification, receiving it at the beginning of January 2021. “Our teams are really pleased,” said Jean-Michel Uhl. “Just over a year after getting the ISO 9001 certification, we are taking a further step that guarantees our customers the high standards of our quality and safety management systems for our medical device components.”

 

Pierhor-Gasser is one of the very first Swiss synthetic stones manufacturers to acquire this certification.

The certification provides a significant competitive advantage for the company, which guarantees compliance with regulatory requirements, control of specific processes, risk analysis throughout the product development and control and traceability of each component for medical devices delivered to our customers.

 

Mixture of “counter-pivots” used as a thrust bearing and “bearing stone” used as a plain bearing. The blue parts are in spinel, the red ones in ruby and the transparent ones in sapphire.

 

>>> To read the press release, click here <<<