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.
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
Navigate compliance with clarity and avoid costly mistakes. I provide strategic guidance to executives, helping them understand regulatory responsibilities, prioritize resources, and align their teams for SaMD success. With my expertise, leadership can confidently make informed decisions that drive compliance and business growth.
Cybersecurity Compliance
Ensure your SaMD is both secure and FDA-compliant from development to post-market. I help organizations simplify and implement cybersecurity requirements, from threat modeling and vulnerability analysis to post-market monitoring. My services protect patient safety, reduce risk, and ensure compliance with evolving regulations.
Quality Management System (QMS) Design and Implementation
Implement a tailored QMS that meets regulatory standards without unnecessary complexity. I design and implement QMS frameworks that align with regulatory requirements while supporting efficiency and scalability. From SOPs to team training, I help you build a system that ensures compliance and drives 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