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Understanding ISO 14155 - (Clinical investigation of medical devices)

ISO 14155:2011 addresses good clinical practice 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 14155:2011 also apply to all other 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 14155:2011 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 14155:2011 does not apply to in vitro diagnostic medical devices.

Dr. Ashok Thakkar
Senior Manager - Clinical Trial

Sahajanand Medical Technologies Pvt. Ltd.

Qualification: Doctorate in Clinical Pharmacology & Masters in Clinical Pharmacy.

Experience: 10 years

Dr. Ashok Thakkar graduated with bachelor of pharmacy degree from Swami Ramanand Tirth Maratha University. He obtained his masters in clinical pharmacy from Sardar Patel University in 2007 and PhD degree in clinical pharmacology from Gujarat University in 2012. He has 9 years working experience in cardiac device trials. He has worked in Central Drugs and Standard Control Organization, New Delhi as a Medical Device Consultant. Currently, he is working as a Senior Clinical Trial Manager in Sahajanand Medical Technologies Pvt. Ltd. Dr. Thakkar is a prolific researcher and author. He has authored over 30 peer-reviewed publications in international journals, over 20 research abstracts/posters and about 20 invited presentations to his credit.