Kalpesh Hegde
My blogs
| Gender | Male |
|---|---|
| Industry | Science |
| Occupation | Operations and Medical Device Regulatory and QMS Expert |
| Location | Scandinavia, European Union |
| Links | Wishlist |
| Introduction | Dr. Kalpesh Hegde a global strategist and operational leader specializing in the orchestration of Operational Excellence, Quality Assurance, and Regulatory Affairs within the international diagnostic and medical device sectors. My career is defined by the strategic scaling of next-generation technologies across Europe, Asia, Japan, NAMER, and the Middle East, where I bridge the gap between complex R&D and global market entry. I provide senior-level oversight for the lifecycle of high-precision platforms, including non-invasive biosensors, continuous glucose monitors (CGM), and fertility and reproductive health systems. My technical portfolio encompasses the infrastructure for Point of Care (POC), Immunoassays, HPLC, and LCMS/MS, focusing on the establishment of advanced manufacturing plants that define the global standard for quality and reproducibility. As a specialist in Class III medical devices, I navigate the high-stakes regulatory pathways of FDA 510(k) and CE IVDR, leveraging ISO 13485 and ISO 14971 frameworks to secure competitive market positioning. |
| Interests | Operational Excellence | Medical Devices & IVDR | Diagnostics Services | ISO 13845: 2016 | MDSAP | USFDA 21CFR | eQMS | IVDR Transition |