• The FDA’s Approach to AI and ML in Medical Devices

    The FDA’s Approach to AI and ML in Medical Devices

    The integration of artificial intelligence (AI) and machine learning (ML) into medical devices has revolutionized healthcare, offering unprecedented capabilities in diagnostics, treatment planning, and patient monitoring. Recognizing the transformative … read more

  • Navigating FDA Compliance: Software as a Medical Device (SaMD)

    In the rapidly evolving landscape of healthcare technology, Software as a Medical Device (SaMD) has emerged as a pivotal innovation. SaMD refers to software intended to be used for medical purposes without being part of a hardware medical device. This … read more

  • Lucky Number 7

    7 years ago, I met a man at a medical device conference and that meeting changed the trajectory of my whole career and brought about my life’s dream – to have my own business. Who is this man, you may ask? Over a cuppa tea, Ron Farrell, VP and Head of … read more

  • MDSAP certification – How to plan for success

    MDSAP is a hot topic right now for all medical device legal manufacturers. In a nutshell, MDSAP certification by an approved Auditing Organisation (AO) proves that your company’s Quality Management System (QMS) is compliant to the Australian, Brazilian … read more

  • The Beginning…

    Neasa-Greene-Medical-Device-Consultant-Graduation

    My love of science began in my first year at Loreto College in Swords, thanks to a very inspiring teacher, Ms. Gore, who taught junior cycle science. I was fascinated by how science could be used to solve complex problems and that the only constant was … read more

How Can I Help Your Project?

If you are a medical device innovator who demands excellence, then contact Neasa Greene Consulting today for an initial consultation.