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.
Every organization is unique, and so are its challenges. I offer customized consulting engagements to address specific needs in SaMD development, compliance, and market readiness. Whether it’s solving a technical challenge, streamlining processes, or preparing for a regulatory submission, I collaborate closely with your team to deliver tailored solutions. My goal is to provide practical, effective support that ensures long-term success and scalability.
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.
Executive Advisory Services
Quality Management System (QMS) Design and Implementation
A robust Quality Management System (QMS) is the foundation of any successful SaMD 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.
Risk Management Framework Development
Effective risk management is essential for SaMD compliance and patient safety. I work with organizations to create comprehensive risk management frameworks aligned with ISO 14971, ensuring that all risks are identified, analyzed, and mitigated effectively. My services include facilitating risk assessments, documenting risk management processes, and ensuring traceability throughout the product lifecycle. With my guidance, your organization can confidently address potential risks and maintain compliance with regulatory requirements.
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.
Cybersecurity Compliance
SaMD Software Development Life Cycle (SDLC) Process Support
Developing SaMD products requires a structured and compliant approach to software development. I help organizations design and implement SDLC processes that meet the requirements of IEC 62304 and IEC 81001-5-1. By training teams to integrate regulatory requirements into their development practices, I help you to make sure your software is developed with quality, safety, and compliance in mind. From design control to verification and validation (V&V), I provide the expertise to streamline your development processes and meet regulatory expectations.
HIPAA and Data Privacy Compliance Support
Compliance with HIPAA and global data privacy regulations is a critical aspect of SaMD development and operation. I help organizations understand and implement processes to protect personal health information (PHI) while meeting regulatory requirements. From developing documentation to advising on best practices, I help make sure your organization is equipped to manage data privacy challenges effectively. My services provide peace of mind, ensuring your products and operations adhere to the highest standards of privacy and security.
Post-Market Compliance and Monitoring
Achieving regulatory clearance is just the beginning—post-market compliance is critical to long-term success. I help organizations establish systems for post-market surveillance, complaint handling, and adverse event reporting. I also develop processes to identify, analyze, and address post-market risks, ensuring continuous compliance and improvement. My support enables you to respond proactively to challenges, maintain regulatory alignment, and deliver value to your customers and patients.
Team Training and Development
Empowering your team with the right knowledge and skills is key to achieving SaMD success. I provide tailored training sessions and workshops on topics such as SaMD compliance, QMS, cybersecurity, risk management, and more. My approach focuses on making complex concepts accessible and actionable, ensuring your team is equipped to meet regulatory and operational challenges. Through mentorship and coaching, I help teams collaborate effectively and drive sustainable results.