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Nuances of Clinical Data Management for Medical Devices - Technical Solutions Perspective

CONFERENCE PRESENTATION · SCDM 2021 Global Conference
Nuances of Clinical Data Management for Medical Devices - Technical Solutions Perspective
  • Session Type: Oral Presentation
  • Session Level: Intermediate
Overview
The session intends to provide details of differences and Nuances of the clinical data management practice for medical devices. This session will include designing of database and CRF, Clinical data and Non-clinical data information along with special attention required in edit checks and IoMT devices etc. This includes both clinical and diagnostic devices.
What You'll Learn
  • Medical device Types and clinical trial requirements.
  • Differences between drug and device clinical studies and Device Specific data management requirements.
  • Regulation applicable to clinical data management for medical devices, including medical coding requirements.
  • Requirements of non CRF and non clinical data and use of modern technology in CDM for medical devices.

Meet the Presenter
Ashish Indani
Senior Manager Clinical Affairs
Stryker
Ashish is Senior Manager Clinical Affairs at Stryker neurovascular and has over 21 years of Clinical Research and Digital Innovation experience in Medical Devices. As a principal scientist in TCS, He has been the part of world’s first Artificial Intelligence based pharmacovigilance processing system development and deployment. He has invented the Nano technology-oriented solution for breath-based detection of cancers and infections and has extended the technology for recreation of as auto adjusting mask, detection of pathogens on nonliving surfaces, circulating air and Sewage water. He has worked on Digital Heart, Digital Nose and AI based preclinical to clinical translation of medical device safety and performance data. Previously as a global Head of clinical Research of Meril, and Sr. Manager Biosensors International, and Medical and Research director Invent and Assistant professor in Medical Institutes, Ashish has authored over 300 Clinical Investigation plans and have conducted about 150 and completed over 100 studies, and 50 CERs. He has a rich Intellectual property portfolio of over 30 publications, 20 patents at various steps of processing and 3 books. He has worked with regulatory bodies of about 120 closely for his work in Medical Devices regulations. He holds Educational Qualifiations of BHMS MBA, MIRCS and ND DY.
Price
SCDM members: $50
Non-members: $175

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