ISO 14155:2020 Documentation and Awareness Training Kit
ISO 14155:2020 documentation and training kit contains more than 85 editable MS-Word files and training presentation ppts. These editable documents and training ppt address all the elements of the Clinical investigation of medical devices for human subjects - Good clinical practice.
Content of ISO 14155:2020 Documentation and Awareness Training Kit
The ISO 14155 Documentation and Training kit for clinical investigation of medical devices contains a set of a total of more than 85 editable files, which are based on requirements of ISO 14155:2020 standard requirements.
Documentation: The documentation part covers the following readymade templates that can be used as a ready reference tool to accelerate the documentation process for ISO 14155:2020 Certification.
- ISO 14155 Manual - Editable medical device quality manual with 10 chapters and 01 annexure for ISO 14155:2020 requirements.
- Procedures - There are 21 mandatory procedures in word format for various requirements.
- Exhibits - sample copy of 06 exhibits that cover all the details in MS Word/excel.
- Standard Operating Procedures - 05 SOPs given with this documentation kit that can use to define safety and care precaution, etc.
- Readymade Formats/ Templates - 49 blank editable sample forms to maintain records as well as establish control and create an effective quality management system in the organization.
- ISO 14155 Audit Checklist - More than 180 audit questions based on the clinical investigation management system for medical devices.
- ISO 14155 Compliance Matrix: 01 Excel has given to understand how the system is made.
Presentation: It includes more than 100 ppt presentation slides as bellow:
- Awareness on ISO 14155:2020 - 16 ppt slides
- ISO 14155:2020 requirements - 113 ppt slides
- ISO 14155:2020 document control and records - 14 ppt slides
- Step for ISO 14155:2020 certification - 06 ppt slides
Literature: A literature to understand ISO 14155:2020 subject well in 04 chapters, 02 workshops, and 01 case study. (Total 60 pages in Ms. Word file)
Features of the Product
- Written in simple English.
- Prepared in .docx format and accessible with MS Word 2007 and later version.
- Anyone can download FREE DEMO with a list of documents that helps to take a quick decision to purchase this documentation kit.
- ISO 14155 Documents are user compatible, easy to learn and easy to use.
- All documents are designed under the guidance of experienced ISO consultants.
- It contains Quality Manual, Procedures, exhibits, sample formats and ISO 14155 Audit Checklist which are a complete set of ISO 14155 documentation as per ISO 14155:2020 standard.
- User-friendly and easy to learn, which minimizes excessive work.
- Defines the baseline system that satisfies requirements for ISO 14155:2020 as well as Good Clinical Practice.
- Most compatible for Clinical investigation of medical devices for human subjects - ISO 14155 documentation for companies in USA, UK, Europe, and Asia.
How This Product is Useful
- Complete set of ISO 14155 manual, procedures, templates, etc., takes care of all the sections and sub-sections to get better confidence as well as improve the system.
- The user/ iso consultants can modify readymade templates as per their working system and they can create their own documents for quick ISO 14155:2020 certification.
- Procedures and formats are provided in document kit can help in fine-tuning the processes and complies with the requirements of system standards.
- This Documentation kit saves much time and costs in document preparation.
- It gives value for money to customers and payback is very low.
- Ready to use templates in .docx format will give accuracy in the documentation process.
More Details
To guide organizations for ISO 14155:2020 certification as per ISO 14155:2020 requirements, GMG is developed this ISO 14155:2020 documentation and training kit. The ISO 14155:2020 standard is required a specific set of documents for its effective implementation and certification. These readymade ISO 14155 documents with a training ppt package is designed to minimize the time and the cost involved in certification as well as better control over the Clinical investigation of medical devices for human subjects.
The Documentation for ISO 14155 contains quality manual, procedures, exhibits, sample forms, audit checklists, etc., which are primary documentation requirements. In Part two, There is available the ISO 14155 Awareness training kit which contains ppt presentations with the user manual. The total documentation for ISO 14155 is designed by Global Manager Group's team of ISO consultants, in editable word templates, which cover all the requirements of ISO 14155 certification, a worldwide popular standard for Clinical investigation of medical devices for human subjects - good clinical practice. The key advantage of this ISO 14155 documents is popular for its user compatibility feature; all the documents covered in 100 MS Word files are editable and written in simple English. It is a globally used documentation tool available with easy editing features and compatible with ISO 14155:2020 requirements. The user can update sample document templates as per the organization's working system and create their own documents for their manufacturing company in just a couple of man-days.
Method of Delivery of ISO 14155 Documentation and Training Kit
Our ISO 14155 consultants are providing a kit of sample documents and training presentation for quick ISO 14155:2020 certification at an introductory price of 810 USD. The contents of this kit are given in the Free Demo. After successful purchase of ISO 14155 documentation and training kit, we will provide username and password for online delivery of this product from our FTP server within 12 to 24 hours.
This product kit softcopy is now on sale. This product is delivered by download from server/ E-mail.
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