ISO 13485 Manufacturing for a Boston-Based Startup
Overview
Digital Health Solutions partnered with a Boston-based medical device startup to establish ISO 13485-compliant manufacturing for a wearable sensor. Our team oversaw every stage of manufacturing readiness from designing and qualifying production equipment to creating the assembly process and validating it through IQ, OQ, and PQ. We developed systems for device history recordkeeping, integrated testing fixtures, and ensured all documentation met FDA requirements. Leveraging our certified facility and deep regulatory expertise, we delivered a pilot manufacturing run of 300 devices and positioned the client for scalable production of up to 5,000 units annually.
Project Highlights
Challenge
Rapid scale-up requirements – Expand manufacturing to
support 5,000 sensors/year within 3 months.
• Regulatory compliance – Meet FDA manufacturing
regulations, including documentation, cybersecurity, and
quality control.
• Complex technology integration – Coordinate hardware,
firmware, mobile app, and cloud backend systems.
• First-time manufacturing – Client engineering team lacked
prior medical device manufacturing experience.
Our Approach
Comprehensive systems engineering– Created all manufacturing requirements and designed the workflow, tools, and systems to meet ISO 13485 standards.
Advanced software development– Built a cloud solution for automated device history records and traceability, for firmware, mobile app, and cloud components.
Automated testing fixtures– Developed programming and Bluetooth test fixtures to configure, verify, and track devices before packaging.
Impact
On-time delivery – Achieved full manufacturing readiness in 3 months, enabling a successful market launch.
Pilot production – Completed a pilot batch of 300 fully compliant sensors.
Regulatory readiness – Delivered all documentation and processes to meet FDA and FCC requirements.
Quality assurance – Validated manufacturing processes with IQ/OQ/PQ for consistent, reliable output.
Takeaways
End-to-end manufacturing readiness – Proven ability to design, qualify, and validate equipment, processes, and workflows under ISO 13485.
Custom fixturing expertise – Skilled in creating precision fixtures and tools that streamline assembly, testing, and quality assurance.
Rapid scale-up capability – Able to move from pilot builds to scalable production volumes under tight timelines.
Regulatory-aligned processes – Deep experience developing documentation, validations (IQ/OQ/PQ), and records that meet FDA and FCC manufacturing standards.