Regulatory Expertise Boston-based engineering and regulatory consulting firm with strong domain expertise in hardware, electronics, firmware, mobile app and IoT/cloud, offering end-to-end product development, V&V, and regulatory services for class II and III medical devices. Opportunity: position as a one-stop partner for CE/FDA compliance, pre-market submissions, and quality management system implementation.

Contract Manufacturing Offers contract manufacturing alongside design and regulatory services, enabling faster time-to-market for medical devices. Opportunity: cross-sell manufacturing capabilities to complement clients’ development programs, especially for prototypes and small to mid-size device releases.

Global Footprint Operations in Boston and India with a growing engineering and regulatory team. Opportunity: target mid-market MedTech companies seeking scalable, cost-effective development and compliance support with global regulatory insights.

Connected Device Focus Core competency in connected device design integrating hardware, firmware, mobile apps, and IoT/cloud components, plus FDA cybersecurity guidance and UX usability expertise. Opportunity: pursue customers building interoperable or remote-monitoring medical devices needing secure, user-centric ecosystems.

Growth Readiness Revenue in the $1M–$10M range and a rapidly expanding team, signaling readiness for larger engagements and multi-project programs. Opportunity: engage as a growth partner for accelerating product development, regulatory pathways, and sustained engineering support as clients scale.