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ISO 14155 Documents - Requirements for clinical investigation of medical devices.

The ISO 14155:2020 is an international standard addresses good clinical practices for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety and performance of medical devices for regulatory purposes. However, it does not apply to in vitro diagnostic medical devices. It is required a specific set of documents for its effective implementation and quick ISO 14155 certification. These ISO 14155 documents should be prepared in such a way so that defines entire implemented system well. A well-designed set of documents help organization 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.

Requirements of Documents for ISO 14155 Certification:


1.      ISO 14155 Manual: The ISO 14155 manual, a mandatory document required for ISO defining and maintaining management system for clinical investigation of medical devices.

2.      Procedures: ISO 14155 procedures documents required as necessary for effective planning, operation, control and monitoring of realization processes improvements. Mandatory procedures cover all the clause requirements to follow while implementation of Clinical investigation and maintaining medical devices.

3.      ISO 14155 Exhibits: ISO 14155 exhibits documents are very useful tools that cover all the details for training to the user to implement the processes and get detail ideas for process implementation and improvement.

4.      Standard Operating Procedures: ISO SOP documents should include documents that define work instructions to link with significant aspects issues in the organization. So, the Standard Operating Procedures take care of all issues and used as a training guide as well as to establish control and make system in the organization.

5.      ISO 14155 Audit Checklist: ISO 14155 Audit Checklist documents that helps you to design audit questionnaire based on ISO 14155:2020 requirements and department wise question. It will be very good tool for the auditors to make audit Questionnaire / clause wise audit Questionnaire while auditing and make effectiveness.


A well-designed set of document addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices. In the global market, many lead ISO consultancy companies and ISO auditors are selling such readymade ISO 14155 documents on the web. Such readymade documents can be used as reference tool that makes overall documentation process easy and fast. One of the leading documents supplier Global Manager Group has just introduced such documents package for ISO 14155 certification, which will be delivered with easy editing features. So, customers can purchase it online from their website and use it as reference material. The ISO 14155 documents must be compatible with ISO 14155:2020 requirements and competences.


Advantages of Effective ISO 14155 Documentation

1.      It minimize the repetition work during documents preparation process.

2.      It saves time and hence cost in process and certification.

3.      The key to having a successful clinical investigation and accelerating your speed to market is to maintain well-documented records.

4.      Such well-designed documents can serve as proof that you’ve followed the ISO 14155 requirements for the clinical investigation of your medical device.

5.      ISO 14155 documents kept up-to-date records in a secure way that easily accessible for quality management system.

6.      The simplest way to achieve this is ideally one that has been built specifically to address the unique needs of medical device manufacturers.

john Smith


ISO Documents Consultant

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