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Clinical investigations
of hardware software system for bioresonance
diagnostics MetatronProduct:
Model 4025 with Metadata GR Hunter software, version 1.9.3.25.
Serial numbers: 94409413, 94409425,
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How to fill out clinical investigations of hardware-software
How to fill out clinical investigations of hardware-software
01
Determine the objective of the clinical investigation
02
Select the appropriate hardware and software to be tested
03
Develop a protocol that outlines the study design, methodology, and data collection procedures
04
Obtain necessary approvals from ethics committees and regulatory authorities
05
Recruit participants for the study and ensure informed consent is obtained
06
Conduct the clinical investigation according to the protocol
07
Collect and analyze the data obtained from the investigation
08
Prepare a report summarizing the findings and conclusions of the investigation
Who needs clinical investigations of hardware-software?
01
Medical device manufacturers who want to obtain regulatory approval for their hardware-software products
02
Healthcare providers who want to evaluate the safety and efficacy of using hardware-software in clinical settings
03
Regulatory authorities who require evidence of the safety and effectiveness of hardware-software before approving its use
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What is clinical investigations of hardware-software?
Clinical investigations of hardware-software refer to the systematic examination of devices and software intended for medical purposes to assess their safety and effectiveness in a clinical setting.
Who is required to file clinical investigations of hardware-software?
Manufacturers and sponsors of medical devices and software that are intended for clinical use are required to file clinical investigations.
How to fill out clinical investigations of hardware-software?
To fill out clinical investigations of hardware-software, one must complete the required application forms, provide detailed information about the device or software, outline the study design, and ensure compliance with regulatory guidelines.
What is the purpose of clinical investigations of hardware-software?
The purpose of clinical investigations of hardware-software is to evaluate the performance, safety, and efficacy of the medical device or software in a real-world clinical environment.
What information must be reported on clinical investigations of hardware-software?
Information that must be reported includes the device description, study objectives, methodology, subject demographics, adverse events, and final results of the investigation.
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