Prepare ISO 13485 Documents Yourself

ISO 13485 documentsISO 13485 was published for the first time in 1996. It presents the requirements for a comprehensive quality management system for the design and manufacturing of medical devices. To achieve ISO 13485 Certification, you must have to implement Quality Management System and prepare ISO 13485 documents that define implemented system well. We offer ISO 13485:2016 Documentation Toolkit that contains a complete set of mandatory and supporting ISO 13485 documents.

Our company also offers ISO 13485 Documentation Consultancy, in which organizations provide us their details via digital platforms, such as e-mail and other mediums, and we prepare ISO 13485 documents for their organization. We also assist them, via web-chat and video conferences, in the use of our ISO 13485 documents for better implementation and auditing of implemented system. The overall process saves time and cost in learning system implementation requirements and documentation process.

ISO 13485 Documents - Manual, Procedures, Checklist

We offer ISO 13485:2016 Documentation Toolkit, which is a set of ready-to-use templates designed as per general version of standard requirements. Our readymade ISO 13485 documents includes the following:

  • ISO 13485 Quality Manual (40 pages)
  • ISO 13485 Procedures (19 procedures)
  • Exhibits (4 exhibits)
  • Blank Formats / Templates (61 sample forms)
  • Standard Operating Procedures (6 SOPs)
  • Process Flow Chart (12 process flow charts)
  • ISO 13485 Audit Checklist (more than 900 questions)
  • Medical Device File (21 files)

The users can implement ISO 13485 themselves, as all they need is given in our ISO 13485 documents toolkits, along with guidance and support. Our toolkit and other resources are developed under the guidance of experienced ISO consultants. So, they are easy to use and understand. The key feature of using such readymade ISO 13485 documents is that they save time and cost in the process of documentation, and hence, ISO 13485 certification.

Recommended List of ISO 13485:2016 Documentation Toolkits

Code Item Description Demo Price Cart
D126 ISO 13485:2016 Documents with Manual, Procedures, Forms, Checklists download $399