Medical Device Software Consulting
Expert Guidance for Navigating the SaMD Landscape
I specialize in guiding companies through the complex and regulated world of Software as a Medical Device (SaMD). With a deep foundation in software development across industries and years of adapting to the stringent requirements of medical device compliance, I bring a unique combination of expertise in software, quality, and engineering operations.
My role is to bridge the gap between your engineering, quality, clinical, and regulatory teams. I work alongside you to understand your software product, develop the necessary documentation for design control and risk management, and implement compliant software development processes. From project start to clearance, I help your company meet the latest regulatory and cybersecurity requirements while preparing for post-market activities.
In essence, I help you transition from being a software developer to a Medical Device Software Manufacturer—a distinction with significant implications.
Whether you’re just starting to develop a medical device product or preparing for submission and post-market success, I provide the expertise and hands-on support to help you succeed.
Contact
Paul Lamoreux
San Francisco, CA
paul.lamoreux@gmail.com
Services
I specialize in guiding organizations through the complexities of Software as a Medical Device (SaMD) development and compliance. With decades of experience in software engineering and years quality management and regulatory development, I provide practical solutions tailored to your unique needs. Whether you’re taking your first steps toward regulatory compliance, preparing for an FDA submission, or refining post-market processes, I offer the expertise and hands-on support to help you succeed. My goal is to empower your team, streamline your processes, and support your SaMD product in meeting the highest standards of quality, safety, and compliance.
These are a few of my most popular service offerings.
Executive Advisory Services
Strong leadership alignment is crucial for navigating the complexities of SaMD development and compliance. I work directly with executives to provide strategic guidance on regulatory and operational decisions. From understanding the responsibilities of SaMD manufacturers to prioritizing resources and risks, I help leadership teams align their vision and actions. My services empower executives to make informed decisions that drive organizational success and regulatory compliance.
Cybersecurity Compliance
Cybersecurity is a critical component of SaMD development, and staying compliant with evolving regulations can be daunting. I help organizations simplify and implement cybersecurity requirements, including the latest FDA guidance and standards such as AAMI TIR-57. From conducting threat models and vulnerability analyses to implementing robust controls and post-market monitoring, I provide end-to-end support. My services help you to ensure your SaMD products are secure and compliant, protecting patient safety and organizational integrity.
Quality Management System (QMS) Design and Implementation
A robust Quality Management System (QMS) is the foundation of any successful medical device operation. I specialize in designing and implementing QMS frameworks tailored to your organization’s unique needs, guiding you to alignment with regulatory standards. From developing Standard Operating Procedures and Work Instructions to training teams on quality best practices, I help you build a system that supports compliance, efficiency, and scalability. My services help you ensure that your QMS is not just a regulatory requirement but a tool for driving continuous improvement.
“Empowerment is about helping others to succeed and to find purpose in their journey.”
– Unknown
Get in Touch
Click below if you are interested in talking about your plans for your medical device software project