t | 01226 350 010

ISO13485:2012 Update acheived

September 2012

After a successful surveillance visit, by Lloyd's Register Quality Assurance to verify our compliance with the requirements of ISO9001:2008 and ISO13485:2003, we have upgraded our certification to ISO13485:2012, demonstrating our commitment to quality and ensuring that we comply with the very latest requirements and regulatory needs.

Although no major changes have taken place, in addition to meeting all the generic requirements in ISO 13485.  when EN ISO 13485:2012 is officially harmonized, before the end of 2012, Oracle Precision will be fully compliant with the Directives 90/395/EEC, 93/42/EEC and 98/79/EC relative to requirements which must be met by manufacturers.

Get in Touch