Medical Device Risk Evaluation Manager
A highly accomplished Quality Management Systems (QMS) and ISO 14971 Risk Management professional with over 10 years of experience in the medical device industry. Specializing in EU MDR gap assessment, technical file remediation, and regulatory compliance for Class II/III medical devices, SaMD, and IVDs. Proven ability to lead global teams and harmonize complex QMS programs, with deep expertise in...
Experience: 11+ years
Amey Kawale provides regulatory consulting services to clients in:
Holding a Master of Science in Mechanical Engineering from the University of Minnesota, Twin Cities, and a Bachelor of Technology and Master of Technology in Mechanical Engineering from IIT Bombay, this professional possesses a robust academic foundation. Their advanced degrees from highly reputable institutions underscore a strong analytical and problem-solving capability, directly transferable to complex regulatory challenges in the medical device industry. This comprehensive education equips them with the technical acumen essential for excelling in demanding regulatory and quality management roles.
With over a decade of progressive experience in the medical device sector, this professional has held significant roles at leading companies including Amazon, Penumbra, Baxter International, and Medtronic. They have a proven track record of managing complex Quality Management Systems (QMS) and ISO 14971 Risk Management programs, successfully overseeing design controls, technical documentation, and inspection-ready files for various device classes. Their experience spans leadership positions in risk management, QMS program management, and engineering management, demonstrating a comprehensive understanding of the entire product lifecycle and regulatory compliance landscape.
A highly accomplished Quality Management Systems (QMS) and ISO 14971 Risk Management professional with over 10 years of experience in the medical device industry. Specializing in EU MDR gap assessment, technical file remediation, and regulatory compliance for Class II/III medical devices, SaMD, and ...
With over 11 years of experience in the medical device industry, this consultant specializes in EU MDR gap assessment, technical file remediation, and regulatory compliance for Class II/III medical devices, SaMD, and IVDs. Holding a Master of Science in Mechanical Engineering and a Bachelor of Technology and Master of Technology in Mechanical Engineering, this consultant possesses a robust academic foundation and deep expertise in risk management processes including Risk Management Plans, DFMEA, UFMEA, PFMEA, Benefit-Risk assessment, Health Hazard Evaluations, and Risk Management Reports. They have successfully managed FDA QMSR projects, ensuring timely compliance, and have a proven track record of managing complex Quality Management Systems (QMS) and ISO 14971 Risk Management programs. This consultant's regulatory expertise depth, FDA experience, and technical competencies make them uniquely valuable for medtech companies.
This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.
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