Design your product with a regulatory path in mind.
- Store regulatory planning documents and standards
- Take credit for the risks and mitigations your engineers intuitively work through
- Structure and filter deliverables by engineering groups using our tags function
Understand and build towards your specific engineering requirements.
- Establish and build your requirements directly from applicable standards and sources
- Annotate and store risks and mitigations in parallel with device engineering
- Trace data types intuitively and flexibly
Access all your engineering, regulatory, and design materials in one place.
- Seamless data management from user needs to design transfer to generate DHFs
- Manage approvals with clear customizable workflows
- Regulatory Analysis and Planning
- Introductory Risk Management Activities
- Review and Development Support for Device Description and Instructions for Use
- Generation of Design Inputs
- Test Planning
- Regulatory Affairs Support for FDA Pre-Submission Meeting Preparation and Follow-up
Trust Us, Compliance Isn’t for Later
Quality and regulatory work don’t need to be at odds with agile product development.
You just have to know what’s most important at each stage.
Let's Work Together
We want to help bring your mission-critical device to market. Get in touch to learn more.
