Biom’Up®, a European-based medical device firm focused on collagen-based absorbable medical products for biosurgery, found itself in search of a medical device development partner to help accelerate the organization’s first Class III Investigational Device Exemption (IDE) and Premarket Approval (PMA) submissions in the United States. This process can take up to 54 months from first communication with the U.S. Food & Drug Administration (FDA) to time of review, and can average $750K in monthly costs for associated FDA activities.
Previously working with a clinical research organization (CRO), Biom’Up found themselves unsatisfied with their delivered outcomes. They required a proven, results-oriented development partner that provided device testing, preclinical capabilities, clinical trial management and regulatory strategy consulting under one roof. They needed an expert team that had extensive experience in successfully navigating the U.S. FDA and IDE/PMA submission pathways, and could offer consistent responsiveness and proactive solutions from project implementation to close-out.
We invite you to read our case study to understand how NAMSA’s MRO® Approach delivered superior results to Biom’Up, including time savings of 23 months and cost savings of $17M+ related to development initiatives.
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