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The ISO 13485:2016 Documentation Kit is helpful for those who want establish effective and good quality management system for the design and manufacture of medical devices and achieve quick ISO 13485 certification.

The editable ISO 13485 documents is to comply with ISO 13485:2016 standard requirements. A readymade ISO 13485 documentation kit for Medical Devices Certification's content is divided into directories such as sample copy of ISO 13485 Manual, Procedures for QMS, Exhibits, SOPs to follow while implementing quality system,sample forms, process approach,Medical device files as well as ISO 13485 audit checklists based on ISO 13485:2016 etc. for quick medical device certification.

This ISO 13485 Documentation Kit is available as Free Demo so that user can do modification as per given editable templates as per their system requirements to create own documents for their organization within minimum time.

For more details visit:

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