Dr. Kalpesh Hegde
Medical Device Operations and Regulatory Affairs in Helsinki
Medical devices and IVD diagnostics professional with 14 years of experience spanning quality, regulatory affairs, and operations. I have built and scaled quality systems from the ground up, led cross-functional teams through complex regulatory submissions, and driven operational excellence across manufacturing and commercial environments.
My technical depth covers Point of Care diagnostics, immunoassay platforms, biosensors, continuous monitoring systems, HPLC and LCMS/MS, and Class III medical devices. I have worked across the full product lifecycle, from early design and risk management through to post-market surveillance and regulatory renewal, across Europe, Asia, Japan, the Middle East, and North America.
On the regulatory front, I navigate FDA submissions, CE marking under MDD and IVDR, MDSAP audit programmes, and the growing convergence of SaMD, AI governance, and ISO 13485 quality frameworks. I have deep experience translating complex regulatory requirements into practical, audit-ready systems that hold up under scrutiny.
Beyond compliance, I have led strategic initiatives in digital health, fertility diagnostics, and personalised medicine, working at the intersection of emerging science and the regulatory frameworks that have yet to catch up with it.
I hold an MPhil from BITS Pilani, a postgraduate qualification in Hospital and Healthcare Management, and professional certifications including ISO 13485 Lead Auditor, MDSAP Auditor, Six Sigma Green Belt, and PMP.
I write, consult, and advise on diagnostics, medical device regulation, and the future of personalised health.