Comprehensive medical device documentation assists in FDA approval

Pulsario partnered with DevDocs to develop comprehensive product documentation in support of FDA approval for its medical device platform.

300+

Pages of content written for medical device FDA approval

15

Process documents written in 3 months

FDA

approved writing from industry experts

About

Pulsario

Pulsario brings AI to the frontlines of home health care. Its remote monitoring platform predicts risk and delivers personalized support for patients with chronic conditions.

Company Type & Size

(11 - 50 employees)

Company Location

USA

Challenge

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.

Solution


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.

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. 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.

"We partnered with DevDocs to overhaul our documentation for several SaaS services, and the results were nothing short of exceptional.

What truly sets DevDocs apart is their flexibility and unwavering commitment to meeting our unique needs. Their unmatched expertise in documentation and their insightful recommendations were instrumental in achieving our goals.

Working with DevDocs has been a game-changer for our team and I wholeheartedly recommend their services to anyone seeking top-tier technical documentation and user experience design."

Marc LeDoux

Full-Stack Developer

Pulsario

View live site →

Want results like these?

Harness the power of a technical writing team with deep development experience. Reach out for a quote.

Or schedule a discovery call now
tech writer 1tech writer 2tech writer 3
1
2

Tell us about your project

The details you provide will allow us to determine an estimate.

Max file size 10MB.
Uploading...
fileuploaded.jpg
Upload failed. Max size for files is 10 MB.
1
2

Contact details

Please provide your best contact information.

Previous step
Next step

Thank you! Your submission has been received.

One of our Customer Success Managers will get in contact with you immediately about next steps on getting your project started!

Oops! Something went wrong. Please Go back and make sure all the necessary info is filled in.
Made with ❤️ and 🌮 in Austin, Texas and serving worldwide