Vision

With a career spanning over two decades, James Hasty has established himself as a leading Quality Engineer in the medical device and software industry. His profound expertise is rooted in a deep understanding of global medical device and software requirements, particularly IEC 62304, which emphasizes first-time quality and sustained compliance.

James's professional journey is marked by a series of prestigious certifications and degrees, including AAMI Certification for Software Validation, ASQ Certified Software Quality Engineer, and a Data Scientist credential from Georgia Tech's Coding Boot Camp. His academic foundation in Electrical Engineering has been the bedrock for his innovative approach to quality assurance and regulatory compliance.

As the CEO and Founder of B&H Engineering Concepts Inc., James has been instrumental in setting the strategic direction of the company, developing and implementing tailored quality management systems, and fostering a culture of excellence. His tenure at Medtronic as a Principal Software Quality Assurance Engineer Consultant saw him update and maintain quality systems, ensuring compliance with stringent regulatory standards.

James's tenure at PHILIPS as a Q&R Compliance Consultant involved managing design control activities and acting as the primary contact with regulatory authorities. His contributions have been pivotal in updating and maintaining quality systems, ensuring that projects and process control documentation align with regulatory requirements.

James Hasty's narrative is one of dedication, innovation, and leadership in the pursuit of excellence in medical device software quality assurance. His legacy is a testament to the impact one individual can have on the industry, shaping the future of medical device software and setting new standards for quality and compliance.