Medica Corporation, a Bedford, Massachusetts-based manufacturer of clinical diagnostics instruments, uses TraceCloud to manage requirements for their blood gas analyzer product lines — including the FDA-cleared EasyStat® and EasyBloodGas⢠platforms. TraceCloud provides full design control traceability from user needs through verification and validation, supporting Medica's FDA submission and ongoing compliance processes.
The Company
Medica Corporation designs, manufactures, and distributes clinical chemistry analyzers used by hospitals, laboratories, and point-of-care facilities worldwide. Their blood gas analyzers — EasyBloodGas and EasyStat — measure critical parameters including pH, pCO2, pO2, and electrolytes for patients with conditions including acute respiratory distress syndrome (ARDS). The products are deployed in over 100 countries and played a notable role during the COVID-19 pandemic, when demand for blood gas testing surged in intensive care settings.
As a medical device manufacturer, Medica operates under strict regulatory requirements including FDA 21 CFR Part 820 (Quality System Regulation), ISO 13485 (Quality Management Systems), and IEC 62304 (Medical Device Software Lifecycle).
The Challenge
Before TraceCloud, Medica managed their requirements and design control documentation primarily through Excel and Word-based processes. For a single-product company with a focused product line, this approach worked — up to a point. The limitations became critical as the product line expanded and regulatory expectations intensified:
- Design control traceability was manual. FDA expects clear linkage from user needs → design inputs → design outputs → verification → validation. Maintaining these traces across separate spreadsheets meant audit preparation was a significant manual effort.
- Risk-requirement linkage was fragile. ISO 14971 requires that risk controls trace to specific requirements. In spreadsheets, these links were cross-reference columns that broke when rows were inserted or files restructured.
- Change impact analysis was incomplete. When a design input changed — which happens regularly during development — identifying every downstream design output, test case, and risk control that needed review required manual inspection.
- Audit preparation consumed engineering time. Producing the traceability matrices required for FDA submissions and ISO audits meant engineers spent days assembling documentation instead of developing the product.
The Solution
TraceCloud was configured to mirror Medica's design control process, structured around the V-model:
- User Needs — What clinicians, lab technicians, and patients need the device to do
- Design Inputs — Measurable, testable requirements derived from user needs and regulatory standards
- Design Outputs — Architecture, specifications, and software design documents
- Risk Controls — Mitigations from ISO 14971 risk analysis, linked to the requirements they protect
- Verification Activities — Test protocols proving design outputs satisfy design inputs
- Validation Protocols — Evidence that the final device meets user needs in its intended environment
Traceability links connect every level of this hierarchy. When an auditor asks "show me the trace from User Need 47 through to its validation evidence," the complete chain is visible in a single trace tree — no manual assembly required.
The Results
FDA traceability documentation ready on demand
Complete traceability matrices for FDA submissions — from user needs through design controls to verification/validation — generated from TraceCloud in minutes, not weeks of manual compilation.
Full V-model traceability for ISO 13485 and IEC 62304
Every design control relationship is maintained as a live, navigable trace — with automatic detection of orphan requirements, dangling test cases, and suspect links when requirements change.
Risk-requirement linkage maintained automatically
ISO 14971 risk controls are linked to the specific requirements they mitigate. When a requirement changes, suspect flags alert the team to review the corresponding risk analysis — preventing gaps that auditors specifically look for.
Engineering time redirected from documentation to development
By automating traceability maintenance and audit report generation, engineering hours previously spent on manual documentation are now spent on product development and quality improvement.
Key Takeaway
For medical device teams, the difference between a spreadsheet-based process and a purpose-built requirements management platform isn't just efficiency — it's compliance confidence. Medica's experience shows that TraceCloud can serve as the backbone of a design control process that satisfies FDA, ISO 13485, and IEC 62304 requirements — while freeing engineers to focus on building the product instead of assembling documentation.
If your team is preparing for an FDA submission or ISO audit and your traceability documentation lives in spreadsheets, Medica's path from Excel to TraceCloud demonstrates that migration is practical, the compliance benefits are immediate, and the dedicated support is there when you need it.