top of page

Key Performance Indicators (KPIs) to Improve Medical Device Registration

Efficient registration of medical devices is critical for accessing global markets, ensuring compliance, and achieving competitive advantages. Establishing robust KPIs (Key Performance Indicators) allows companies to measure progress, streamline processes, and optimize resource allocation. Drawing insights from global trends and tools like international market strategies for start-ups, here are the essential KPIs to enhance medical device registration:

​

1. Time to Prepare Dossier

  • Why It Matters: A streamlined dossier preparation process shortens market entry timelines and reduces costs.

  • Best Practices:

    • Utilize templates aligned with IMDRF or market-specific guidelines.

    • Automate repetitive tasks with regulatory tools.

  • Target KPI: Reduce preparation time by 20% compared to the previous registration cycle.

 

2. Time to Answer Deficiency Questions

  • Why It Matters: Delayed responses to regulatory deficiencies can prolong approvals and hinder launches.

  • Best Practices:

    • Maintain a central repository of previous deficiency responses.

    • Train teams for rapid and accurate responses.

  • Target KPI: 95% of deficiency questions answered within regulatory deadlines.

 

3. Prioritized Country Rollout

  • Why It Matters: Prioritizing high-potential markets maximizes ROI and ensures strategic global presence.

  • Best Practices:

    • Use data-driven insights to select target markets.

    • Monitor emerging regulatory trends (e.g., MDR in Europe or NMPA in China).

  • Target KPI: Rollout medical devices in at least 3 new prioritized countries annually.

 

4. Quality Management (QM) Renewal

  • Why It Matters: Regular renewal of quality certifications like ISO 13485 or Japan QMS ensures compliance and operational excellence.

  • Best Practices:

    • Conduct annual internal audits.

    • Assign a dedicated team for QM compliance tracking.

  • Target KPI: Achieve 100% on-time renewal of QM certifications.

 

5. Additional Testing Demands

  • Why It Matters: Managing unplanned testing efficiently avoids project delays and cost overruns.

  • Best Practices:

    • Partner with accredited laboratories for quick turnarounds.

    • Create a buffer in project timelines for unforeseen tests.

  • Target KPI: Complete additional testing within 10% of the planned timeline.

 

6. Registered Medical Devices per Employee in Critical Markets

  • Why It Matters: This KPI measures the productivity of regulatory teams in key markets.

  • Best Practices:

    • Invest in training and automation tools.

    • Benchmark performance against industry standards.

  • Target KPI: Register at least 2 medical devices per regulatory employee per year.

 

7. Number of Design Change Assessments

  • Why It Matters: Design changes during the lifecycle of a device can impact regulatory compliance and marketability.

  • Best Practices:

    • Use a centralized system for tracking design changes.

    • Conduct risk assessments before submitting changes.

  • Target KPI: Complete 100% of required assessments within stipulated timelines.

 

8. Passed Inspections and Audits

  • Why It Matters: Regulatory inspections and audits are critical for maintaining market access and avoiding penalties.

  • Best Practices:

    • Implement mock inspections.

    • Maintain audit-ready documentation.

  • Target KPI: Achieve a 95% success rate in regulatory inspections and audits.

 

Strategies to Achieve These KPIs:

  • Leverage Technology: Use digital tools to automate dossier preparation, monitor progress, and track regulatory changes.

  • Enhance Communication: Foster collaboration between global teams to ensure smooth exchanges of regulatory requirements.

  • Benchmark Performance: Compare your metrics with industry standards to identify gaps and areas for improvement.

 

What can we support

Implementing these KPIs allows medical device companies to measure, track, and continuously improve their regulatory processes. By focusing on time, compliance, and team productivity, manufacturers can reduce registration timelines, ensure compliance, and achieve a seamless rollout across multiple markets.

​

In our personal workshop in DACH region, our coach will have an interactive workshop after controlling your regulatory KPI. At end each participant will find solution to optimise registration work.

bottom of page