Premarket Regulatory Support

We offer proactive, strategic, and efficient solutions to bring your vision to market

Navigating the regulatory pathway for medical devices requires more than just compliance; it demands a proactive and strategic approach. Our seasoned team of regulatory experts combines deep industry knowledge with a keen understanding of market dynamics.

We believe that regulatory decisions should not be isolated, but instead, harmoniously aligned with your broader business goals.

A meticulously crafted market launch strategy ensures that your medical device not only enters the market smoothly, but thrives in a competitive landscape. We collaborate closely with your team to develop a comprehensive plan that encompasses regulatory compliance, market positioning, and streamlined testing plans considering long term strategies.

  • Prioritize markets based on regulatory complexity and market potential

    • Consolidate unique regulatory requirements into the project plan

    • Optimize planned testing to include region-specific nuances and endpoints. Small adjustments may allow you to leverage a test to satisfy the regulatory authorities in more than one market.

    • Ensure that documentation is generated according to regional expectations (e.g., FDA CFR Design Controls, MDR Technical File, COFEPRIS Dossier)

    • Develop biocompatibility testing strategies compliant with ISO 10993s here

    • Identify label requirements according to international standards and regulations

    • Steer barcode system development (e.g., GS1 requirements)

    • Advise (or execute) requirements for mandatory regulatory device identification databases (e.g., FDA GUDID, EUDAMED, PARD)

    • Assist with GMDN or other health coding

  • Our consultants can serve as:

    • document content generators or approvers, 

    • design control phase gate review representatives for Regulatory or Quality, 

    • impartial reviewers

    • strategic advisors

    • regulatory impact assessments and justifications

  • 10 years of submission experience, including:

    • Q-submission / premarket submissions

    • FDA clarification meetings

    • 510(k) Premarket Notification

    • predicate identification

    • Substantial Equivalence testing strategy

    • Experience with Medical Electrical Equipment, including software and IEC 60601 testing 

    • Presentation of biological evaluation data

    • eSTAR template

    • Register your firm with FDA with the correct activities, and correctly linked with your device listings

    • Advisement on CFG (Certificate to Foreign Government) organization and strategic grouping of products