The ISO 14155:2020 documentation and training kit is a comprehensive set of editable MS Word files and training presentation PPTs that address all elements of clinical investigation of medical devices for human subjects. The kit includes an editable manual, 21 mandatory procedures, exhibits, standard operating procedures, ready-made templates, an audit checklist, and a compliance matrix. The presentation includes over 100 PowerPoint slides covering awareness, requirements, document control and records, and certification steps. The kit is written in simple English and is accessible with MS Word 2007 and later versions. The documents are user-friendly and easy to learn, designed under the guidance of experienced ...
The ISO 14155:2020 documentation and training kit is a comprehensive set of editable MS Word files and training presentation PPTs that address all elements of clinical investigation of medical devices for human subjects. The kit includes an editable manual, 21 mandatory procedures, exhibits, standard operating procedures, ready-made templates, an audit checklist, and a compliance matrix. The presentation includes over 100 PowerPoint slides covering awareness, requirements, document control and records, and certification steps. The kit is written in simple English and is accessible with MS Word 2007 and later versions. The documents are user-friendly and easy to learn, designed under the guidance of experienced ISO consultants. The kit is most compatible with companies in the USA, UK, Europe, and Asia, and is designed to minimize excessive work.
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