ISO 13485 consultants developing and implementing an effective Quality Management System meet the standard requirements of ISO 13485 for medical devices regulation requirements. We are also provides ISO 13485 standard documentation are includes ISO13485 manual, quality system procedures, SOPs, formats and audit checklists as well as ISO 13485 implementation any organization.
ISO 13485: 2003 speaks to the prerequisites that medical device makers must join into their administration frameworks. The current archive supersedes its 1996 incarnation and in addition EN 46001, EN 46002 and ISO 13488. thanks a lot!
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