SoftwareCPR Employee Directory

Medical Equipment ManufacturingFlorida, United States11-50 Employees

SoftwareCPR, a subsidiary of Crisis Prevention and Recovery LLC, operates as a regulatory consulting firm focused on FDA oversight for medical devices, pharmaceuticals, and biologics. Its services encompass quality systems compliance, premarket submissions, design control, risk analysis, software validation, cybersecurity, and related regulatory affairs activities, with additional offerings through a subscription service that provides regulatory information, training aids, and reference materials. The firm works with clients in the medical product sector to navigate regulatory requirements, participate in standards and policy development, and support negotiations with regulatory authorities, aiming to streamline compliance processes and reduce time to market. Based in the Tampa area, Florida, SoftwareCPR positions itself within the medical equipment manufacturing ecosystem by leveraging practitioners with hands-on regulatory experience and training capabilities, including workshops and collaboration with FDA internal software experts. The organization serves as a professional partner for manufacturers seeking guidance across quality systems, medical device reporting, and software-related regulatory considerations, and it recently added personnel to its Regulatory Associate team.

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