Yogireddy Amireddy

Med Tech Quality and compliance professional with 8 years of experience in the global medical device industry. Skilled in sustenance engineering, design chang management,
verification and validation (V&V), test method validation (TMV), EU MDR transition, and ISO/IEC regulatory frameworks. Proven ability to lead DHF remediation, ensure compliance continuity across product lifecycles, and collaborate effectively across
global sites to support audit readiness and regulatory alignment.

MedTech V&V, Quality and Compliance professional with 8 years of experience in the global medical device industry. Your expertise spans verification & validation (V&V), DHF remediation, EU MDR compliance, test method validation (TMV), and ISO/IEC regulatory frameworks. You’ve consistently contributed to audit readiness, regulatory alignment, and lifecycle compliance across multiple organizations.

Core Skills: 

Regulatory & Compliance: ISO 9001, ISO 13485, ISO 14971, EU MDR 2017/745.

Validation Expertise: V&V, TMV, IQ/OQ/PQ, risk management, packaging validation.

Tools & Software: MS Office, Visio, Minitab, AutoCAD, SolidWorks, Windchill, Siemens Teamcenter, TrackWise, PM Smart.

Certifications: ISO Internal Auditor, IATF Core Tools, ASNT NDT Level II (VT, RT, UT, MPT, PT).

Bachelor of Technology (B.Tech) in Mechanical Engineering Guntur Engineering College, affiliated with Jawaharlal Nehru Technological University, Kakinada 2014 – 2018 | First Class