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Medical Devices Quality System ISO 13485:2016 Documentation

We offer certification consultancy and total documentation for quality management system for the design and manufacture of medical devices. So far many companies globally have taken our services and successfully developed quality management system with our help. We have a team of highly-experienced quality management system (QMS) consultants to guide medical device manufacturing companies on system implementation, documentation and training process, and help them establish effective and good quality system and get quick certification. The ISO 13485:2016 certification audit is done by accredited certifying body auditors. Our QMS consultants develop and produce a management system that complies with the requirements of customers and pre-eminently-of various global regulators.







Our company offers Quality System for Medical Device - ISO 13485:2016 Documentation Kit, which is ready-to-use solution for quick documentation process for easy certification. We have developed readymade documentation kit for Medical Devices Certification that organizations need to demonstrate their ability to provide medical devices with quality system certification and to consistently meet customer requirements. There are requirements applicable to medical devices and related services to establish quality system. During implementation of ISO 13485, documentation, including manual, procedures, policies, operating instructions and forms are prepared by the companies to establish a good working system. Our experienced Quality system consultants have designed such quality documents to help medical device manufacturing companies establish effective documentation.

Contents of Readymade Templates Included in Our Documentation Kit


 Sample ISO 13485:2016 Quality Manual  (40 pages in Word document).

 Procedures for quality management system (19 procedures)

 Exhibits and Operating Procedures to follow while implementing quality system (04 Exhibits and 06 SOPs).

 Set of formats and templates for maintaining records (61 sample forms).

 Process flow chart, which guides to establish good process approach.

 Medical device technical files (total 21 files in Word document).

 Audit Checklist - to verify implemented quality management system for medical device.

The entire QMS documentation kit is well-written in English and provided in editable .doc format, so that your documents will be ready just with minimal editing. You can purchase the total documentation kit for Medical Device QMS with easy editing features and compatible with system requirements. It is a very effective tool to learn and implement QMS documentation, completely meeting the demands of the updated system requirements.


ISO 13485:2016 Documentation Kit - Manual, Procedures, Checklists

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