ISO 13485:2016 documents contain more than 100 editable MS-Word files. These editable documents address all the elements of medical device quality management system
Our ISO 13485:2016 manual documentation kit consists of the following documents in editable .doc format.
Medical devices - Quality management systems - Requirements for regulatory purposes represent the requirements that the medical device manufacturers must incorporate into their management systems. These QMS requirements are becoming popular among the medical devices' manufacturers
The ISO 13485 Certification is based on the quality management system, which helps to implement medical device preventive system. The ISO 13485 certification ensures very safe use of medical devices as per quality system guidelines.
Global Manager Group has designed ready-to-use ISO 13485:2016 documents kit to comply with Medical Devices manufacturing QMS. Our ISO 13485 documents include Quality Manual, quality system procedures, SOPs, formats and ISO 13485 audit checklist. The entire set of ISO 13485 documents is designed in the editable .doc format. A user can use this ready-to-use tool while preparing for ISO 13485 Certification. It has been developed by and is also being used by our ISO 13485 consultants while conducting corporate training sessions and implementing ISO 13485 system in many pharma and medical device manufacturing companies. Our team has prepared these documents in compliance with all the necessary requirements. Our documents kit helps a user to modify the templates as per their products and create documents for their organization in a quick time.
By downloading Free DEMO, a user can understand the content of documentation kit, which helps them to easily take the decision to purchase our products. The user can purchase it online via secured third party payment gateway or via Bank wire transfer as mentioned in the Payment Option on each page. Once a user purchases the ISO 13485:2016 Medical device - QMS documentation kit, we provide a username and password within 12 working hours for online E-delivery of our products via our FTP server.