Sravan Kumar Manchikanti
Biomedical Engineer | Medical Device QARA | QMS - ISO 13485 Lead Auditor | Design Controls, DHF, Risk, Usability, SaMD
- Role
- Regulatory Affairs Project Manager at Lumenis
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Sravan Kumar Manchikanti
I am a dynamic Biomedical Engineering graduate turned entrepreneur with 16+ years of expertise across medical device R&D, manufacturing, quality, regulatory, and clinical development. My experience spans multiple sectors—manufacturing, consulting, and start-ups—giving me comprehensive knowledge of end-to-end medical device development.Specializing in Quality Assurance and Regulatory Affairs (QARA), I have guided global clients through regulatory pathways, technical file preparation, and obtaining crucial approvals. As an empaneled ISO 13485:2016 auditor for a notified body, I conduct ISO 13485 and CDSCO audits, ensuring compliance with global standards. Additionally, I have led and trained teams, conducted supplier audits, and established QMS as a certified ISO 13485:2016 Lead Auditor.I am passionate about driving medical device compliance and innovation while sharing my knowledge through training on ISO 13485, ISO 14971, and harmonized standards:• Certified ISO 13485:2016 Lead Auditor• QMS Implementation & Auditing• Regulatory submissions (US, EU, India, Canada, etc.)• Expertise in Design Controls & DHF• Regulatory and quality training for teams
Experience
Regulatory Affairs Project Manager
Jan 2022 — Present
Education
Jawaharlal Nehru Technological University
B.Tech, Biomedical Engineering
2004 — 2008
Vignan's Foundation of Science, Technology & Research, Guntur
Intermediate, MPC
2002 — 2004
ZPHS, Sankara Bharathi Puram, Narasaraopet
SSC
1997 — 2002
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