FDA-ready documentation clears regulatory path for MedTech startup
300+ pages and 15 process documents in 3 months to meet FDA submission requirements.
The challenge
Pulsario, a medical-device manufacturer, sought FDA clearance for a new device but lacked the necessary procedures and submission documentation. The company needed help designing FDA-compliant practices and documenting them clearly, which required expertise spanning medical-field compliance, government documentation standards, agile processes, API documentation, and product testing.
What we did
DevDocs interviewed Pulsario team members to understand their needs and regulatory requirements, then created standardized templates for every process. An experienced technical writer established an agile development process to improve workflow and feature traceability, identified new workflows for feature testing, release notes, and defect management, and documented the device-development lifecycle from conception through release, including risk-management files. DevDocs also corrected formatting issues and misleading instructions in existing content and created user documentation for unreleased features.
Outcome
DevDocs wrote more than 300 pages of content and created 15 process documents in 3 months so Pulsario could meet government submission requirements. Standardized templates and processes kept the documentation clear, compliant, and efficient to produce while preparing the medical-device platform for FDA review and future customer use.
“Their expertise in documentation and insightful recommendations were instrumental in achieving our goals.”
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