SaMD Product Definition & Sizing | Medical Device Planning Services | Orthogonal

222 W Merchandise Mart Plaza #228, Chicago, IL 60654
(312) 374-6490
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Launch your SaMD product reliably with Orthogonal's Product Definition & Sizing service. We help medical device companies close the gap between product vision and successful launch through a structured 3-6 week planning process. Our cross-functional team delivers key deliverables including functional requirements, regulatory and quality strategy, clinical risk management, cybersecurity, UX/human factors, and a technical approach. We provide clear timelines, resource allocation, costs, and tradeoff options to align your organization for predictable execution. Before you begin software as a medical device development, take this critical first step to establish what you’ll need, what you’ll get, and when it will be ready. Contact Orthogonal to start your SaMD planning conversation.