ISO 14155 2011.pdf is a document that contains the international standard for clinical investigation of medical devices for human subjects. It is also known as Good Clinical Practice (GCP), which is an ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve human participants.
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If you are planning to conduct a clinical investigation of your medical device for regulatory purposes, you need to follow the requirements of ISO 14155 2011.pdf to ensure that:
- You protect the rights, safety and well-being of the human subjects
- You ensure the scientific conduct and credibility of the clinical investigation results
- You define the responsibilities of the sponsor and principal investigator
- You assist the ethics committees, regulatory authorities and other bodies involved in the conformity assessment of your medical device
ISO 14155 2011.pdf is based on the principles of the Declaration of Helsinki, which is a statement of ethical principles for medical research involving human subjects. It also harmonizes with other global guidelines, such as ICH-GCP, which is a guideline for good clinical practice issued by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.
ISO 14155 2011.pdf covers various aspects of clinical investigation, such as:
- Study design and planning
- Risk management
- Data management and quality control
- Monitoring and auditing
- Adverse event reporting and analysis
- Clinical investigation report writing and archiving
To access ISO 14155 2011.pdf, you can visit the official website of ISO, which is the International Organization for Standardization. ISO is an independent, non-governmental organization that develops and publishes international standards for various fields and industries.
Alternatively, you can download ISO 14155 2011.pdf from our website by clicking on the link below. We offer a free trial period for our customers who want to access our library of standards and documents. You can also subscribe to our service and enjoy unlimited access to our resources.
Download ISO 14155 2011.pdf here
ISO 14155 2020 is the latest edition of the international standard for clinical investigation of medical devices for human subjects. It was published in July 2020 and replaces ISO 14155 2011, which was withdrawn.
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ISO 14155 2020 is an update and revision of ISO 14155 2011, which reflects the current state of the art and best practices in clinical investigation of medical devices. It also aligns with other relevant standards and regulations, such as ISO 14971 for risk management, ISO 13485 for quality management systems, and the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR).
Some of the main changes and additions in ISO 14155 2020 include:
- A new section on clinical performance and effectiveness, which clarifies the definitions and concepts of these terms and how they relate to safety
- A new section on software as a medical device (SaMD), which provides guidance on how to apply the standard to SaMD, considering their unique characteristics and risks
- A new section on risk-based monitoring, which describes how to plan and implement a monitoring strategy that is proportionate to the risk level of the clinical investigation
- A new section on electronic data systems and data protection, which covers the requirements for using electronic systems for data capture, management, storage and transfer, as well as the protection of personal data and privacy
- A new annex on guidance for ethics committees (ECs), which outlines the roles and responsibilities of ECs in reviewing and approving clinical investigations
ISO 14155 2020 also provides more details and examples on various topics, such as study design, risk management, data management, adverse event reporting, clinical investigation report writing, and archiving.
To access ISO 14155 2020, you can visit the official website of ISO, which is the International Organization for Standardization. ISO is an independent, non-governmental organization that develops and publishes international standards for various fields and industries.
Alternatively, you can download ISO 14155 2020 from our website by clicking on the link below. We offer a free trial period for our customers who want to access our library of standards and documents. You can also subscribe to our service and enjoy unlimited access to our resources.
Download ISO 14155 2020 here 8cf37b1e13