Workshop for international markets: Supporting Every Stage of the Registration Process

1. Market Entry for Start-Ups

   • Challenge: Start-ups often face resource constraints and lack in-house expertise for registration.

   • Solution:

     • Identify target markets based on product type and company goals.

     • Prepare comprehensive technical documentation aligned with IMDRF or specific country guidelines.

     • Assist with local representation requirements (e.g., EU Authorized Representative or NMPA China Agent).

 

2. Optimizing Technical Documentation

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• Challenge: Preparing compliant technical documentation is time-intensive, and deficiencies can delay approvals.

• Solution:

  • Develop a centralized, standardized structure for technical documentation.

  • Integrate global requirements, such as ISO 13485 and IEC 62304, into documentation.

  • Consolidate documents with clear version control to avoid confusion and miscommunication.

• Why It Matters?
  With streamlined documentation, companies can reduce time to approval while ensuring consistency across multiple registrations. Learn how we address quality management system requirements.

 

3. Efficient Deficiency Management

• Challenge: Responding to regulatory authorities’ deficiency queries can be time-consuming and resource-draining.

• Solution:

  • Track all communication and revisions in a centralized system.

  • Train teams to draft deficiency responses efficiently and effectively.

  • Utilize data from previous submissions to anticipate common deficiencies.

• KPI: Ensure 100% of deficiencies are answered within specified deadlines, minimizing approval delays.

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4. Lifecycle Management of Regulatory Registration

• Challenge: Maintaining compliance and managing post-approval changes can overwhelm regulatory teams.

• Solution:

  • Establish KPIs such as "number of design change assessments" and "time to respond to additional testing demands."

  • Provide tracking systems for milestones such as QM renewal, clinical testing updates, and country-specific re-registration.

  • Offer on-demand consulting for challenges like audits, inspections, and multi-market rollouts.

 

KPI-Driven International Registration

To help companies achieve measurable success, we implement the following Key Performance Indicators:

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• Time to Prepare Dossier: Reduce preparation time by utilizing expert templates and automation.

• Deficiency Response Time: Ensure swift replies to authority queries to prevent delays.

• Country Rollout Efficiency: Expand into prioritized markets with optimized strategies.

• Registered Devices Per Employee: Measure productivity and efficiency of regulatory teams.

• Inspection Pass Rate: Achieve a high success rate in regulatory audits and inspections.

 

Why Partner With Us?

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1. Comprehensive Expertise:

   • From start-ups to large enterprises, our team has supported companies across the globe, helping them navigate regulatory complexities in the EU, US, China, and beyond.

2. Custom Solutions:

   • Whether you need support for a single registration or a global compliance strategy, we offer flexible, scalable services tailored to your needs.

3. End-to-End Support:

   • Our services cover the entire lifecycle of regulatory registration, from dossier preparation to post-approval compliance.

4. Technology Integration:

   • We utilize electronic tools to trace document changes, manage KPIs, and ensure seamless communication with regulatory authorities.

 

Next workshop: Taking Control of Your Medical Device Registration

 

Let us help you take the complexity out of international registration. Whether you’re preparing to enter new markets or optimizing your current registration portfolio, our services are designed to save time, reduce costs, and ensure compliance.

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In our personal workshop in DACH region, our coach will have an interactive workshop after controlling your regulatory KPI. Even you are start-ups we can evaluate next steps using our Starter-kit.