ISO 14155:2026 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 95 editable files, which are based on requirements of ISO 14155:2026 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 14155:2026 Certification.

1. ISO 14155 Quality Manual - Editable medical device quality manual with 10 chapters and 01 annexure for ISO 14155:2026 requirements.
2. Quality Procedures - There are 21 mandatory procedures in word format for various requirements.
3. Exhibits - sample copy of 07 exhibits that cover all the details in MS Word/excel.
4. Standard Operating Procedures - 05 SOPs given with this documentation kit that can use to define safety and care precaution, etc.
5. 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.
6. ISO 14155 Audit Checklist - More than 400 audit questions based on the clinical investigation management system for medical devices.
7. ISO 14155:2026 Document Compliance Matrix: 01 Excel has given to understand how the system is made.

Presentation: It includes more than 100 ppt presentation slides as bellow:

1. Awareness on ISO 14155:2026 - 23 ppt slides
2. ISO 14155:2026 requirements - 180 ppt slides
3. ISO 14155:2026 document control and records - 23 ppt slides
4. Step for ISO 14155:2026 certification - 10 ppt slides

Literature: A literature to understand ISO 14155:2026 subject well in 04 chapters and 01 case study. (Total 60 pages in Ms. Word file)

Workshops and Case study: 02 workshops with 20 questions to solve and 01 case study with 05 questions for practical understanding of ISO 14155:2026 requirements.

• Developed under the guidance of experienced ISO 14155 consultants and clinical research experts in accordance with ISO 14155:2026 – Good Clinical Practice (GCP) requirements and international best practices.
• Includes a comprehensive documentation package comprising the ISO 14155 Manual, procedures, ISO 14155:2026 audit checklist, forms, records, exhibits, sample formats, and training materials required for clinical investigation of medical devices involving human subjects.
• Establishes a robust documentation framework that complies with ISO 14155:2026 requirements and supports Good Clinical Practice (GCP) throughout the clinical investigation process.
• Written in clear, simple English for easy understanding, implementation, and day-to-day use.
• Supplied in fully editable Microsoft Word format, compatible with MS Word 2007 and later versions, enabling quick customization to meet organizational requirements.
• User-friendly, implementation-ready templates simplify documentation, reduce administrative effort, and accelerate compliance with ISO 14155 requirements.
• User-friendly and easy to learn, which minimizes excessive work.
• Includes a FREE DEMO with the complete document index and ISO 14155:2026 sample documents, allowing users to review the package contents before making a purchase decision.
• Suitable for medical device manufacturers, clinical research organizations (CROs), sponsors, investigators, and healthcare organizations across the USA, UK, Europe, Asia, and other international markets conducting clinical investigations in accordance with ISO 14155:2026.

Benefits of the ISO 14155:2026 Documentation and Training Kit

• Includes a complete set of ISO 14155:2026 documents, including the ISO 14155 Manual, procedures, SOPs, forms, records, templates, internal audit checklists, and ISO 14155:2026 Awareness Training PowerPoint presentations, covering the requirements of Good Clinical Practice (GCP) for clinical investigations involving medical devices.
• Fully editable Microsoft Word templates and customizable PowerPoint training presentations enable organizations and consultants to tailor both documentation and employee training to their clinical investigation processes.
• The implementation-ready procedures, formats, ISO 14155:2026 audit checklist and awareness training materials help standardize clinical investigation activities, strengthen process controls, and promote organization-wide understanding of ISO 14155:2026 requirements.
• The included awareness training presentations support effective employee training, helping investigators, study personnel, and project teams understand their roles, responsibilities, and Good Clinical Practice (GCP) requirements.
• Professionally developed templates and training materials significantly reduce the time, effort, and cost involved in documentation preparation and staff awareness, enabling faster implementation.
• Ready-to-use ISO 14155 documents and training resources accelerate implementation, improve documentation accuracy, and simplify compliance with ISO 14155:2026.
• The comprehensive kit delivers excellent value by combining documentation and training resources in a single package, reducing dependence on external consultancy and supporting a faster, more efficient implementation process.

More Details About the ISO 14155:2026 Documentation and Awareness Training Kit

To help organizations implement ISO 14155:2026 and achieve compliance with the latest requirements for Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice (GCP), Global Manager Group has developed a comprehensive ISO 14155:2026 Documentation and Awareness Training Kit. This implementation-ready package is designed to simplify documentation, strengthen compliance, and significantly reduce the time, effort, and cost associated with implementing an effective clinical investigation management system.

The ISO 14155:2026 standard requires comprehensive documentation and personnel awareness to ensure that clinical investigations are planned, conducted, monitored, recorded, and reported in accordance with Good Clinical Practice principles. Our documentation and training kit provides all the essential resources needed to establish a compliant system and prepare organizations for successful implementation. The package includes a complete set of professionally developed documents, such as the ISO 14155 Quality Manual, procedures, Standard Operating Procedures (SOPs), forms, records, templates, exhibits, and ISO 14155 audit checklists. In addition, the kit includes ISO 14155 Awareness Training PowerPoint presentations with handouts and other training materials, enabling organizations to effectively train investigators, study personnel, quality teams, and other employees on the requirements of the standard.

Developed by an experienced team of ISO consultants and medical device quality professionals, all documents and training materials are based on the latest ISO 14155:2026 requirements and internationally recognized Good Clinical Practice (GCP) guidelines. Every template is professionally prepared, fully editable, and written in clear, easy-to-understand English to simplify implementation across organizations of all sizes. The entire documentation package is supplied in editable Microsoft Word format, while the awareness training materials are provided as customizable Microsoft PowerPoint presentations, allowing organizations to tailor both documentation and training to their clinical investigation processes and organizational practices.

One of the key advantages of the ISO 14155:2026 Documentation and Awareness Training Kit is its flexibility. Organizations can quickly customize the templates and training presentations to create their own documentation and awareness programs within a few days. This user-friendly, implementation-ready solution helps medical device manufacturers, clinical research organizations (CROs), sponsors, and healthcare organizations accelerate implementation, improve compliance, and establish an effective ISO 14155:2026-compliant Good Clinical Practice (GCP) system with confidence.

Our ISO 14155 consultants are providing a kit of sample documents and training presentation for quick ISO 14155:2026 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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