Hasret Ergüven Email & Phone Number

Dedicated and results-driven Biomedical Engineer with a passion for ensuring the highest quality and regulatory compliance in the medical device industry. I am a graduate of Ankara University with a degree in Biomedical Engineering, and I currently serve as a Consultant specializing in Quality Assurance and Regulatory Affairs (QA&RA) within the medical device sector.I have built a solid foundation in Biomedical Engineering, and my career has evolved into a consultancy role in Medloft Consultancy Doo where I actively contribute to the success of medical device projects. My commitment to maintaining the highest standards of quality and compliance has been instrumental in achieving successful outcomes for clients.I am an ambitious and collaborative professional with a proven track record of success in the medical device industry. Known for my ability to work both independently and as part of a team, I am an effective time-user, determined, and proactive in managing projects.My expertise lies in the development and implementation of quality management systems, with a focus on key areas such as Medical Device CE Technical File and 510(k) Submission, Risk Management, Clinical Evaluation, PMS, Complaint Management, and Vigilance processes. Through a meticulous and strategic approach, I ensure the seamless execution of projects, meeting regulatory requirements and achieving optimal results.With a commitment to excellence and a proactive mindset, I consistently navigate the complexities of the regulatory landscape, contributing to the success of projects and the overall advancement of healthcare solutions.

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  Ankara University

  3,72/4