ISO 13485:2003 Certification and Initial Export


PT INDEC Diagnostics has officially obtain ISO 13485:2003 field of In Vitro Diagnostics (IVD) on 5 September 2012. The certificate was awarded by BSI which is an international certification body based in the United Kingdom (UK) with UKAS accreditation. Handover certification conducted by Mr. Aryo Gustomo represents BSI and Mr. Adie Suryo as Director of PT INDEC Diagnostics.

PT INDEC Diagnostics is one of the subsidiaries in Sevana Group, whose main business is the manufacture of In Vitro Diagnostic Reagents. "By obtaining ISO 13485:2003 certification, the PT INDEC Diagnostics is the first manufacturing company to obtain ISO 13485:2003 certification in Indonesia which produce In Vitro Diagnostics Clinical Chemistry in particular," according to a statement delivered by Mr. Teddy from Arrowhead Consulting.

This certification complements existing certifications PT INDEC Diagnostics previously achieved the ISO 9001:2008 certification and certification of SGS, and GMP (how to manufacture medical devices that either / CPAKB) of the Ministry of Health of Indonesia.

At the same time do also release prime export product, which symbolically carried out by Mr Suroso as Commissioner Sevana Group. Clinical chemistry products are exported to Thailand and Vietnam market goals. [MR]



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