Digital Health Solutions

Digital Health Solutions is a Boston-based engineering and regulatory consulting firm focused on end-to-end product development and contract manufacturing for medical devices. With a rapidly growing team of top skilled engineers and regulatory experts in our Boston and India offices, we help medical device and MedTech companies bring their medical products quicker into market by leveraging our strong domain expertise in hardware, electronics, firmware, mobile app, and IoT/cloud components, as well as in quality V&V and regulatory services. We have deep experience in working on product ideation to design & development, product re-engineering, testing and verification & validation, sustenance engineering, contract manufacturing, quality assurance, regulatory compliances and submission. Our core competency includes- Connected device design integrating hardware, electronics, firmware, mobile app, and IoT/cloud components - Proficiency in IEC 62304, ISO 13485, and ISO 14971 for class II and devices - Compliance with FDA cybersecurity guidance - UX design, Usability and Human Factors - Full Regulatory Services - Contract Manufacturing