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 Certification Documentation

D126 : ISO 13485 Medical Device Documentation Kit

399.00 USD Demo

Medical devices - Quality management systems - Requirements for regulatory purposes, represents the requirements that medical device manufacturers must incorporate into their management systems are becoming very popular in the medical device manufacturers. The ISO 13485 is based on ISO 9001 standard for quality management system. ISO 13485 based quality management system helps to implement medical device preventive system that ensures very safe use of medical devices as per quality system guidelines.

Global Manager Group has designed Ready to use document kit for ISO 13485, which covers ISO13485 manual, quality system procedures, SOPs, formats and ISO 13485 audit checklists. The entire ISO 13485 document is designed in editable .doc format and can be used as best ready to use tool while ISO 13485 certification. It has been developed and is also being used by our quality consultants while conducting corporate training sessions and implementation of ISO 13485 in many pharma and medical device manufacturing companies. Our team has prepared documents conforming to the requirements of ISO 13485 standard and many clients globally are already certified using our document kit. The user can modify the templates as per their products and create own ISO13485 documents for their organization.


Content of ISO 13485 Manual, Procedures, Checklists Documents

Our ISO 13485 documentation kit consists of the following documents in editable .doc format.

  • ISO 13485 Manual - a quality system manual as per clause wise requirements of ISO 13485 standard (37 pages in word document)
  • ISO 13485 Procedures - list of mandatory procedures to follow while ISO 13485 implementation (18 procedures- 54 pages in word document)
  • Exhibits - Sample copy of mandatory exhibits (3 exhibits - 3 pages in word document)
  • Sample Formats / Templates - Ready to use verified ISO 13485 forms for quick ISO documentation (37 blank formats - 50 pages in word document)
  • Quality SOP - Set of sample standard operating procedures (6 SOPs - 19 pages in word document)
  • ISO 13485 Audit Checklist - Audit checklists of over 900 audit questions as per ISO 13485, which can be customized to make your own internal audit checklist.
  • Written in Plain English.
  • Hand-outs written in word 7 and window 2000.
  • The soft copy of EN ISO 13485 document kit and audit questions is provided.
  • Free ISO 13485 pdf documents are given.
  • ISO 13485 Manual and other quality system documents are developed under the guidance of experienced quality experts.
  • It will save much time in typing and preparation of presentation as well as medical device document preparation.
  • User-friendly and easy to learn.
  • Defines the baseline system that satisfies standard requirements that customized to suit your ISO 13485 requirements.
  • Provides model of quality system documentation that is natural, simple and free from excessive paperwork.

How ISO 13485 Documents are Useful for Quick Documentation

  • Contains ISO 13485 quality manual, procedures, SOPs, sample templates and formats that comply with ISO 13485 standard.
  • Our ISO 13485 kit is ideal for individual learning as well as group training to ensure successful implementation of quality management system for medical devices.
  • Provides you with the sample ISO13485 based document kit and hand-outs that you need for effective quality documentation and implementation.
  • By using our globally used editable documents, you can save a lot of your precious time and money while preparing the course materials for in-house documents and SOPs to create cultural change in the organization.
  • Perfect tool to educate all employees on ISO 13485 and to achieve better performance of Medical devices in pharma sector.
  Other Details

This ISO 13485 document kit soft-copy is now on sale. Documents shall be delivered by E-mail/ftp download as instant E delivery.

  • ISO 13485 quality manual
  • ISO 13485 quality procedures
  • work instructions / SOPs
  • ISO 13485 Formats/Templates (more than 60)
  • Department wise and ISO 13485 standard requirement audit checklist (more than 900 audit questions)

Method of Delivery for ISO 13485 Document Kit

User can purchase it from our website via secure third party payment gateway or via wire transfer as mentioned in Payment Option on each page. After purchase of our ISO 13485 document kit, we will give you username and password for online E-delivery of our products by ftp download from our server.

This product kit softcopy is now on sale. This product is delivered by download from server/ E-mail.

For more details on System Certification, Contact Us or to see demo of our products, visit our E-Shop.
D126 : ISO 13485 Medical Device Documentation Kit 399.00 USD Demo
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We provide the complete set of documents as per related standard requirements covering policy, manual, procedures, forms, records, Standard Operating Procedure, audit checklist..more..
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