Navigating Compliance in Medical Device Manufacturing

Welcome to MedTech Compliance! I'm Ayub Yancheshmeh, a seasoned Compliance and Standards Engineer based in sunny Orange County, California. With a robust background in medical device standards and compliance, I specialize in ensuring that healthcare technology meets the highest safety and efficacy standards.

I lead quality management systems and certification testing, collaborating with third-party labs to achieve rigorous certification standards. My role is pivotal in advancing medical device safety, particularly through my work on the IEC 60601-1 4th edition project, where I co-convene efforts to address thermal and fire hazards. Additionally, I am leading the project for the 3rd edition of the IEC 60601-2-24 infusion pump standard, ensuring the highest levels of safety and performance for these critical devices.

I hold a Master's degree in Biomedical Engineering and have over 15 years of experience in the medical device field. My expertise extends to design control, Product safety and EMC standards (IEC 60601-1 series), risk management (ISO 14971), usability (IEC 62366-1), and software (IEC 62304) consulting and training. I have a comprehensive understanding of the regulatory landscape, including the FDA, and the importance of integrating these elements to ensure the development of safe and effective medical devices. I also provide training sessions to share my knowledge and help others in the industry stay updated with the latest standards and best practices.

My journey in the medical device industry has been marked by significant contributions to international technical committees, including IEC TC62 and ISO TC121. As a Vice Chair of the SCC MC ISO TC121/SC3 and a member of various technical committees, I am dedicated to setting benchmarks in medical equipment standards, ensuring global health and safety.



As a consultant, I offer my expertise to help your organization navigate the complexities of medical device compliance and standards. Whether you need assistance with quality management systems, certification testing, or training on the latest standards, I am here to support your goals. Let's connect and explore how we can collaborate to advance healthcare technology and ensure the highest levels of safety and efficacy for your products.