Dr. AKASH SHARMA

About

I'm a seasoned Regulatory Affairs and Quality Management System professional specializing in medical devices. With expertise in navigating complex regulations like EUMDR, QMS (ISO13485), MDSAP, WHO-PQ, Risk Management, and GMP, I help companies achieve and maintain compliance. Currently, I serve as the Head of Regulatory Affairs & Quality Assurance at Revital Healthcare (EPZ) Limited in Kenya, leading a team to ensure regulatory compliance in the healthcare sector. My background includes a role as a Management Representative & Manager- Regulatory Affairs at Kaulmed Private Limited, and I've held key positions as a Research Engineer, Scientist-'C', and Quality Engineer. Academically, I hold M.Tech (ME). and Ph.D. (ME) degrees and have authored 40+ research papers and 10 books in the healthcare and regulatory field, positioning me as a thought leader committed to advancing knowledge and contributing to industry discourse.

Employment

• Revital Healthcare (EPZ) Limited Head
  2023 - Present
• KAULMED PRIVATE LIMITED Manager / Management Representative
  2020 - 2023

Education

Education history is unavailable.

Projects & Funding

Projects & funding information is unavailable.

Publications (23)

• Mechanical Properties and Tribological Behavior of Grain Refined WE43 Magnesium Alloy
  Archives of Metallurgy and Materials 2025 2 citations DOI: 10.24425/amm.2025.152543
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• The Effects of Heat Inputs on LDSS 2101 GTAW and SMAW Weld Microstructure and Mechanical Behavior
  Archives of Metallurgy and Materials 2024 4 citations DOI: 10.24425/amm.2024.149798
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• Injecting Quality Care: Syringes and their Impact on Precision Medicine in Healthcare
  Journal of Pharmaceutical Research International 2023 3 citations DOI: 10.9734/jpri/2023/v35i327471
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• Risk-Based Quality Management in Healthcare Organization
  Notion Press 2023
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• An Overview of the Importance of Fogging Disinfection Method in the Healthcare Setups
  Journal of Pharmaceutical Research International 2023 1 citation DOI: 10.9734/jpri/2023/v35i47319
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• Recent Development in Friction Stir Welding: An Advancement in Welding Technology
  Lecture Notes in Mechanical Engineering 2022 2 citations DOI: 10.1007/978-981-16-3135-1_20
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• The Effect of Different Conditions on the Tensile Properties of AA7075-T6 During the Friction Stir Welding Process
  Archives of Metallurgy and Materials 2022 2 citations DOI: 10.24425/amm.2023.142466
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• Role of Regulatory Affairs in a Medical Device Industry
  Current Journal of Applied Science and Technology 2022 7 citations DOI: 10.9734/cjast/2022/v41i2931797
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• Management of distal unstable radius fractures with locking distal radius plates: a retrospective study
  International Journal of Research in Orthopaedics 2022 0 citations DOI: 10.18203/issn.2455-4510.intjresorthop20223263
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• Clinical outcomes of the intramedullary humerus nailing system in the treatment of humerus fractures
  International Journal of Research in Orthopaedics 2022 1 citation DOI: 10.18203/issn.2455-4510.intjresorthop20223453
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