How medical device documentation assisted in FDA approval

Challenge

Pulsario, a medical device manufacturer, sought FDA clearance for a new medical device but lacked the necessary procedures and documentation for approval. They contacted DevDocs for assistance with designing FDA-compliant practices, documenting the required processes, and creating additional submission documentation.

Creating documentation for government approval requires technical writers who are 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

DevDocs was able to deliver on all the requirements to ensure the project was successfully submitted for FDA approval. Our experienced tech writers created an agile development process to improve Pulsario's workflow and traceability of features. We identified several new workflows for testing features, creating release notes, and managing defects, ultimately helping Pulsario improve documentation quality and operational efficiency. We also 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.

Our technical writers improved the readability of Pulsario's existing content by correcting formatting issues and misleading instructions, preparing their services for Beta release seamlessly. We additionally created user content for unreleased features, ensuring Pulsario's clients continue to derive value in the future.

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Results

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. Once the FDA accepts the documentation and processes, the medical device will be marketable to the general public.

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