Elevate Medical Device Software Device Development Compliance and Quality
Our multidisciplinary team brings together three core specialties to implement and support Software as a Medical Device (SaMD) developers in achieving regulatory compliance and quality management success: medical device Regulatory Affairs and Quality Assurance (RAQA) expertise, advanced software tools for automated Software Development Life Cycle (SDLC) documentation, and SDLC-optimized Quality Management System (QMS) design and implementation. Our comprehensive approach, grounded in years of experience, ensures seamless integration of compliance and quality into every stage of your SaMD development process, so you can navigate the ever-evolving regulatory landscape with confidence and precision.
Our Team
Josh Davidson
Software Development
Josh is a veteran of the software development industry and a founder of Mellitus Health, a pioneering SaMD company that developed the first FDA-cleared insulin-titration-recommendation system for virtually every dosing combination.
Mike Margolese
Software Development
Mike is deeply experienced as a hardware and software engineer and a founder of Mellitus Health, a pioneering SaMD company that developed the first FDA-cleared insulin-titration-recommendation system for virtually every dosing combination.
Ken Blaker
Testing and Documentation
Ken is a veteran of the avionics and in-flight software industry and, at SaMD Compliance, lead developer for a platform featuring automated testing, document generation, and a single environment for cross-traceable risks, requirements, and tests.
Noam Young
Quality Management
Noam is a BSI-certified ISO 13485 Lead Auditor and ISO 9001 Team Leader who specializes in documentation, QMS design and improvement, and audit preparedness and strategy.
Tim Duggins
Regulatory Compliance
Tim is a regulatory compliance and QMS expert who helped develop the ISO, IEC, and CSA standards and test methods used in the medical device, pharmaceutical, and biologicals industries.
Ready to get started?
Let us help bring your SaMD product to market!
