ISO 14155 CLINICAL INVESTIONS OF MEDICAL DEVICES -- Good Clinical Practices
good clinical practices
for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.
The principles set forth in
ISO 14155 Standard
apply to all clinical investigations and should be followed as far as possible, depending on the nature of the clinical investigation and the requirements of national regulations.
ISO 14155 specifies general requirements intended to protect the rights, safety and well-being of human subjects, ensure the scientific conduct of the clinical investigation and the credibility of the results, define the responsibilities of the sponsor and principal investigator, and assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.
does not apply to in vitro diagnostic medical devices.
ISO 14155 Certification
URS indicates organization's
adherence to Management practices and as a truely Auditing Firm, offers Value Addition Auditing Services in Auditing. Auditing Services of URS are designed to meet Global Standards that deliver Credibility in Certification. To Achieve this objective, professionally trained auditors are deputed to identify 'Opportunities for Improvements'in ISO 14155 Certification.
ISO 14155 Standard
is applicable to all types of organizations irrespective of size or nature such as Hospital, Health Care, Trading, Service Companies, Software,
in India. URS offers ISO 14155 Certification in all cities,
Recognition of Certification for certified clients are recorded on
and details shall be accessed through 'Client Zone' on URS website.
ISO 14155 Certification has following Benefits:
ISO 14155 Certification has benefits for clinical practice organizations
- Emphasis of this standard is to protect human subjects,
- Ensure the reliability of scientific conduct during the clinical investigation,
- Establishes Good Clinical Practices,
- Assist sponsors, monitors, investigators, ethics committees, regulatory authorities, and bodies involved in assessing medical device conformity.
Certificate issued by URS are accepted world over – Why Choose URS
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