Strategy Service

EMPOWER can unlock the door to global markets for your medical device with a personalized, step-by-step strategic roadmap, designed to help your organization effectively navigate regulatory landscapes and achieve business objectives.

The Value

Of A Regulatory Strategy

  • Establish a compliant foundation for your device from the onset, mitigating the risk of costly remediation and delays in subsequent expansion stages.

  • Analyze and understand the regulatory requirements of your target markets, forging a clear pathway for market entry and acceptance.

  • Demonstrate a minimized risk profile and a methodical approach towards market access.

  • Prioritize and allocate resources effectively through a nuanced understanding of the regulatory milestones and timelines.

  • Foster clear communication and alignment among stakeholders through well-defined regulatory milestones and objectives.

What’s Included?

  • Client Goals Assessment: Align with your business objectives, target markets, and desired timelines to ensure a tailored regulatory approach.

    Device Analysis: Delve into the specifics of your medical device, gathering essential information that will form the foundation of your regulatory strategy.

  • Market Analysis: Map out the regulatory landscape of your target markets and identify comparable products to inform your strategy.

    Device Classification: Ascertain and justify your device’s classification in target markets, which is pivotal for determining submission pathways and data requirements.

    Submission Strategy: Identify the most appropriate submission pathway and outline the required data, aligning with a suggested project timeline to meet your business milestones.

    Post-market Strategy: Advise on post-market activities ensuring compliance with surveillance, renewals, and adverse event reporting requirements.

    Risk Analysis: Highlight potential risks and devise mitigation strategies to tackle challenges that may arise during the regulatory journey.

    Stakeholder Communication Plan: Strategize on interfacing with regulatory bodies, prepping for meetings, and crafting clear, compelling messaging.

  • Present a draft strategy, address your queries, and incorporate your feedback for a strategy that resonates with your vision and expectations.

  • Deliver a comprehensive regulatory strategy report that provides a clear pathway to market authorization and, where possible, accelerated market entry.

Get Started

To get started with EMPOWER on your tailored regulatory strategy, fill out the following form and you will be contacted within 48 hours. We look forward to partnering with you!