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Five hours of regulatory services to support a high-level regulatory assessment. Senior leadership at Experien will meet with the company (either over the phone or at the San Jose office) to gain an understanding of their technology and anticipated regulatory pathway. Experien’s team will review all pertinent product materials and conduct a search of FDA guidance documents and applicable predicate devices. The team will provide a basic report, outlining a general assessment of the likely U.S. FDA regulatory pathway for device commercialization. A follow-up call can address any questions related to Experien’s output.
Experien Group is a full-service medical device consulting firm, offering comprehensive support in the areas of regulatory affairs, quality systems, pre-clinical and clinical research and data management. We pride ourselves in serving as an extension of our client’s team, setting strategies and executing to major milestones. While we have office locations in both Northern and Southern California, we collaborate with clients from around the globe ranging from agile MedTech startups to multi-national MedTech corporations.