Pre-Market and In-Market Regulatory Support
Streamline regulatory submissions and responses, and ensure compliance for faster approvals.
Expert guidance you can trust
Ensure product safety and effective PMA, 510(k) and New Drug Applications (NDA) submissions to the Food and Drug Administration (FDA) with expert guidance from the industry leader. Med Safety Board (MSB), powered by ISMP and ECRI, a federally approved Patient Safety Organization (PSO), MSB provides you with access to real-world clinicians (nurses, pharmacists, physicians, and other healthcare professionals) and clinically informed human factors engineers to help you ensure faster, more efficient and successful FDA product approvals.
End to end support tailored to your needs
Leverage our deep medical device, medication-related device, and pharmaceutical safety knowledge to navigate safety protocols and streamline your submission or response process for optimal results. From device labeling and packaging to clinical data interpretation, product naming, and human factors processes—we tailor our guidance to meet your unique needs. Additionally, we conduct thorough risk assessments to identify potential safety concerns in device design or use-process, ensuring a smoother submission process and better alignment with regulatory requirements for successful approval.
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Insights and Qualitative Research
Collaborate with experts to gather data-driven insights, identify safety concerns, and improve pharmaceutical and device safety.
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