RegNav Solutions
Your Clear Path Towards Compliance
Our software solutions harness the power of AI technology plus expert review to deliver standards and requirements for Class I, II and III medical devices.
Whether you are starting your medical device journey or you’re a seasoned regulatory professional, we have a solution that is right for you.
RegNav is flexible to your project needs - whether you are prepping for a Qsub or need a full regulatory strategy, our expert backed tool is here to help.
Verify
Expert validation of an existing compliance plan:
Verify Standards
Easy to use tool that ensures you’ve identified all applicable standards for your project.
Design Change Impact Assessment
Evaluate how modifications in design affect your compliance strategy.
Expert Validation
Industry experts validate each plan.
Premium
A full compliance plan, product classification and timeline in 2 weeks or less:
Pre or Post Design Freeze
Whether you're at the design stage or after it, we can identify the applicable standards for your device.
Comprehensive Regulatory Outline
Receive a full outline of regulations and standards required for your medical device, ensuring you’re fully informed.
Expert Validation
Industry experts validate each plan.
Premium Plus
Everything in RegNav Premium, plus product-level requirements for enhanced planning and decision-making:
Product-Level Requirements
Receive a detailed list of requirements your device needs to adhere to.
Verification Planning
Understand verification method for each requirement to ensure compliance.
Expert Validation
In-depth expert review of your compliance plan, ensuring thoroughness and alignment with industry standards.
FDA Product Code Finder
Try our new complimentary FDA product code finder to find matching product codes for your medical device.
Why Choose RegNav?
AI-Technology
Leverage advanced technology for timely and accurate decision-making.
Expert Backing
Benefit from our team’s industry knowledge and experience.
Flexibility
Solutions that adapt to your project needs, whether for due diligence or full regulatory strategy.