Product & Delivery Setup
Business Analysis for FDA-Regulated Healthcare IoT Product
Healthcare company · US stakeholders · EU-based R&D team
The Challenge
Developing a Bluetooth-enabled medical device for asthma diagnostics and treatment monitoring required navigating complex regulatory requirements (HIPAA, GDPR), aligning US business stakeholders with an on-site R&D engineering team, and maintaining requirements traceability across a 3-year program.
What We Did
- Delivered full business and functional requirements documentation for hardware, firmware, and mobile application components
- Wrote user stories and acceptance criteria aligned with HIPAA and GDPR regulatory requirements
- Facilitated stakeholder alignment between US business owners and local R&D engineering team
- Maintained requirements traceability across the full product lifecycle
- Supported regulatory certification process and market launch preparation
Results
Product successfully launched to market
Regulatory certification obtained
3 years of consistent delivery across a complex, multi-team regulated program
Zero critical requirements gaps during certification review