Sethuraman Rama

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Dr Sethuraman Rama

Head of Quality and Regulatory
APAC Roche Diagnostics
Asia Pacific

Dr Rama is currently the Director, Medical Devices Branch, Health Sciences Authority (HSA). She has been working in the area of Medical Devices Regulations for over 8 years now. Prior to joining the HSA, she was involved in Research on chronic pain and neuropathic pain at the National University of Singapore, identifying novel small peptide and amino acid markers related to pain in the cerebrospinal fluid of chronic pain patients and developing novel diagnostic methods using principles of chemistry in the analysis of biological samples. Dr Rama received her PhD from the School of Medicine in NUS in 2006. She holds the Professional certification on Regulatory Affairs on Global regulations from the Regulatory Affairs Professional Society (RAPS). 

Dr Rama currently represents Singapore as a member of the Management Committee of the International Medical Device Regulators Forum (IMDRF) and is a member of the working group that is developing the guidelines on Clinical Evaluation and Evidence for Software as a Medical Device in the IMDRF. In addition, Dr Rama is also the current Chair of the Software as Medical Devices Work Group (WG3) in the Asian Harmonisation Working Party (AHWP) Technical committee.

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