Company Performance Metrics
Rx Device Consulting provides medical device product development and regulatory consulting with a focus on digital health, wearable technology, software, artificial intelligence, imaging, and additive manufacturing. The company advises clients on strategy and product launch, including technology roadmaps, prototyping, software verification and
validation, human factors testing, and risk management. It supports scaling operations through reimbursement strategy, contract manufacturer selection, distributor vetting, and quality management system setup and audits. Rx Device Consulting also assists with clinical trial execution, product validation test plans, and regulatory strategy, including preparation and submission of 510(k) applications and CE Mark technical files. The firm offers cybersecurity and software design control assessments, threat modeling, and ongoing security testing for connected and software-based medical devices. Its services are aimed at startups and established manufacturers developing medical devices, digital health platforms, and AI-enabled solutions.
