How medical device documentation assisted in FDA approval

Challenge

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Pulsario, a medical device manufacturer, sought FDA clearance for a new medical device but needed the necessary procedures and documentation for approval. The company contacted DevDocs for assistance in designing FDA-compliant practices, documenting the required processes, and writing additional submission documentation.

Creating government-approved documentation requires technical writers familiar with industry best practices and product compliance. This task required an expert writer with knowledge in the medical field, government documentation, agile processes, API documentation, and product testing.

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Solution

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Pulsario chose DevDocs for its specialty in process documentation and SOP consulting services that promote small business growth and development. DevDocs delivered on all the requirements to ensure a successful submission for FDA approval. DevDocs began the process by interviewing Pulsario team members to understand their needs and regulatory requirements fully. The DevDocs team then created standardized templates for all processes, which allowed for a consistent and streamlined approach to documenting each stage of the FDA submission.

An experienced technical writer created an agile development process to improve Pulsario's workflow and traceability of features. DevDocs identified several new workflows for testing features, creating release notes, and managing defects, ultimately helping Pulsario enhance documentation quality and operational efficiency. DevDocs additionally documented the development processes of the medical device from initial conception through release, including their risk management file documentation, another required component of an FDA submission.

Templates became critical in managing the complexity and ensuring efficiency throughout the project, particularly for managing technical documentation across different stages of development. DevDocs' technical writer improved the readability of Pulsario's existing content by correcting formatting issues and misleading instructions, preparing their services for Beta release seamlessly. Also created was user content for unreleased features, ensuring Pulsario's clients continue to derive value in the future.

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Results

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DevDocs wrote hundreds of pages of content and created 15 documents in 3 months to deliver the required documentation so Pulsario could meet the government submission requirements. Using standardized templates and processes, DevDocs ensured the documentation was clear, compliant, and efficiently produced. Once the FDA accepts the documentation and updated processes, the medical device will be marketable to the general public.