ISO 14155 CLINICAL INVESTIONS OF MEDICAL DEVICES -- Good Clinical Practices in Kalyan for Hospitals and Medical Services

ISO 14155

addresses

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.

ISO 14155

does not apply to in vitro diagnostic medical devices.

ISO 14155 Certification

by

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 Hospitals and Medical Services

in India. URS offers ISO 14155 Certification in all cities,

in Kalyan

India.

Recognition of Certification for certified clients are recorded on

URS Website

and details shall be accessed through 'Client Zone' on URS website.
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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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ISO 14155 Certification Services in Kalyan for Hospitals and Medical Services

ISO 14155 Certification in Kalyan is issued by URS. The ISO 14155 is applicable to all type of Organizations such as ISO 14155 for Hospital & Health Care in Kalyan, ISO 14155 for Trading in Kalyan, ISO 14155 for Manufacturing in Kalyan, ISO 14155 for Service Companies in Kalyan, ISO 14155 for Software Companies in Kalyan, ISO 14155 for Medical Devices in Kalyan, ISO 14155 Construction in Kalyan can implement the ISO system as per ISO 14155 and URS awards the ISO_14155 Certification in Kalyan.

Training Services in Kalyan for Hospitals and Medical Services

ISO 14155 Auditor Trainings are delivered by URS in Kalyan. Auditor Training Courses are designed such that the participants gains the subject knowledge and auditing skills, the auditor courses are accepted worldwide. Organizations can apply to ISO 14155 Auditor Trainings in Kalyan to URS at training@ursindia.com.

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