Global Regulatory Strategy & Submission Support
Successful market entry requires more than checklist compliance. It requires a nuanced understanding of how different regulatory bodies evaluate human factors evidence. We provide tailored strategies for:
Expert guidance for 510(k), PMA, De Novo, and Breakthrough Device designations. We help you define your Use Specification and ensure your Use-Related Risk Analysis (URRA) is defensible under FDA scrutiny.
We advise on the full scope of global usability engineering requirements, helping clients understand what compliance looks like for their specific product and market, including:
IEC 62366-1:2015+AMD1:2020, the global benchmark for usability engineering for medical devices
ISO 14971, risk management with a focus on use-related risk analysis
EU MDR/IVDR usability requirements
Regional guidance for NMPA (China), MHLW/PMDA (Japan), and MHRA (UK) submissions
Meet Your Lead Strategists
Your engagement will be led by consultants with decades of hands-on experience across medical device development, FDA negotiations, and international standards work.
Director of Human Factors Strategy & Advisory
With over 25 years of experience in the medical products industry, Denise is an expert in implementing usability engineering processes, conducting use-related risk analyses, formative evaluations, and validation testing across a wide range of medical technologies, from home-use devices to complex robotic surgery systems. She develops human factors submission strategies and documentation for FDA and international regulatory compliance, successfully guiding clients through submissions and audits.
Director of Human Factors Strategy & Advisory
With more than 18 years of experience in both product development and human factors engineering roles, Jenny holds a master's degree in Applied Ergonomics from the University of Nottingham. She has deep expertise in building HFE processes and integrating them into research and development activities from product conception through launch, as well as creating robust human factors engineering strategies, validation plans, and documentation that meet the requirements of global regulations across the US, Europe, China, and Japan.
Intergrated Expertise
Combination Products: Navigating the unique cross-center (CDRH/CDER) requirements for injectors, inhalers, and other drug-device combinations.
Surgical Robotics: Managing the high cognitive load and complex use environments of the modern operating room.
Digital Health & SaMD: Applying human factors engineering principles to software-only medical devices.
