Prepare ISO 13485 Documents Yourself

ISO 13485 documentsISO 13485 was published for the first time in 1996 that represents 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 defines implemented system well. We offer ISO 13485:2016 Documentation Toolkit that contains complete set of mandatory and supporting ISO 13485 documents.

The company also offer ISO 13485 Documentation Consultancy, in which organization provides us their details via digital platforms such as email and other resources and we prepare ISO 13485 documents for their organization. Also assist them how to use ISO 13485 documents for better implementation and auditing of implemented system via webchat and video conferences by using our ISO 13485 documentation toolkit. The overall process saves time and costs 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. This readymade ISO 13485 documents consists of following list of documents:

  • 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 by itself as all they need is in our ISO 13485 documents toolkits, along with included guidance and support. Our toolkits and other resources were developed under the guidance of experienced ISO consultant for ease of use and to be understandable, with no expert knowledge required. The key feature of using such readymade ISO 13485 documents is that it saves time and cost in 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