ISO 14155 (Clinical investigation of medical devices for human subjects-Good clinical practice)
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
adherence to Management practices and as a truly Auditing Firm, offers Value Addition Auditing Services in Auditing. Auditing Services of we 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 Laboratory Services
we offer ISO 14155 Certification in all cities, in India.
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 thereliability of scientific conductduring the clinical investigation,
• EstablishesGood Clinical Practices,
• Assist sponsors, monitors, investigators, ethics committees, regulatory authorities, and bodies involved in assessing medical device conformity.