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Services
Strategy & Product Launch
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Defining your technology roadmap, and implementing hardware and software prototypes
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Software V & V testing and human factors testing
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Risk management
Scaling Operations
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Defining a reimbursement strategy
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Identifying and vetting a CM to scale production and distributors to drive sales
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Setting up and maintaining an efficient Quality Management System, including providing audit support
Clinical Trial Execution
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Identifying key clinical milestones, and developing a clinical trial and product validation test plan
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Planning your regulatory strategy
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Preparation and submission of 510(k) applications to FDA
Client Success Stories: Wearable Device for Seizure Detection
Rx Device Consulting partnered with a startup developing a revolutionary wearable device that uses high-resolution electrodermal activity (EDA) and accelerometer sensors, combined with sophisticated machine learning algorithms, to continuously monitor and detect seizures in epilepsy patients.
Collaborating closely with the executive team, we managed the regulatory process for multiple 510(k) applications with the FDA. We engaged directly with FDA reviewers in the Neurology division through pre-submission meetings, 510(k) discussions, and breakthrough device designation meetings. These efforts led to the device receiving breakthrough device designation status from the FDA. Additionally, we assisted in drafting the technical file for the product's successful CE Mark submission.
Our support extended beyond regulatory affairs. We provided valuable input on clinical trial protocols and statistical analysis plans, conducted human factors testing, and oversaw software and hardware verification and validation (V&V) testing. We also facilitated biocompatibility testing and ensured electrical safety and electromagnetic compatibility (EMC) testing were completed to the highest standards.
This comprehensive approach helped our client bring a groundbreaking medical device to market, enhancing patient care and positioning the company as a leader in epilepsy management solutions.
Our Promise:
Precision You Can Trust, Innovation You Can Rely On
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