I.Ceram — Regulatory Filings 2017

Sep 25, 2017

ISO 13485:2012 Certification renewed

I.CERAM, specialized in innovative orthopedic implants and ceramic implants with a great biocompatibility has obtained the renewal of its ISO 13485:2012 COFRAC certification in relation with its quality system management, for its medical devices and associated services.

Since its origin, I.Ceram's main goals are its customer satisfaction and the respect of norms and legislation. Thus, the society implemented a rigorous quality system in order to provide a complete security and excellence for its products, from their design to their delivery.

The audit performed by ABcertification validates the conformity of I.Ceram quality system management in regards to ISO 13485:2012 COFRAC dedicated to medical devices industry.

The renewal of this international norm, prerequisite to CE marking, fits into I.Ceram development planning and testifies the high level of its quality system.

All information: www.iceram.fr

About I.CERAM:

Created in 2005 in Limoges, France, I.CERAM designs, manufactures and commercializes orthopedic orthopedic implants and ceramic implants offering a unique biocompatibility (11 international patents). The wealth of knowledge and expertise from over 30 years of its managers has enabled I.CERAM to accelerate its bioceramic development. I.CERAM is labeled as an "innovative company", ISO 9001, ISO 14385 certified and CE certified. With 42 employees and a production tool at the forefront of technology, I.CERAM shows a very high potential to continuously develop. On December 2014, the company was listed on the Alternext stock exchange (Euronext Growth Paris). ISIN : FR0011511971 – ALICR

Financial communication Solène Kennis Tel : +33 (0)1 75 77 54 68 skennis@aelium.fr