Streamline medical documentation with AI-driven workflows

Power your Document Management System with AI to accelerate document generation and processing ensuring accuracy, consistency and compliance

Facing the pressure of managing complex, high-stakes documentation? We understand.

We create tailored AI solutions that enable MedTech companies to handle intricate, high-volume documentation while ensuring accuracy, traceability, and full regulatory compliance at every stage of the document lifecycle.

up to 10 %

savings in US healthcare spending is expected to be generated by wider adoption of AI

85%

is a projected compound annual growth rate for generative AI in healthcare through 2027

70%

healthcare organizations are pursuing or have already implemented GenAI capabilities

Optimize the entire medical document lifecycle with AI-first products

We architect your solution, making it easier to manage the full document lifecyclefrom drafting clinical reports and handling patient data to preparing regulatory submissions, coordinating multi-stakeholder reviews, securing approvals, and completing audits.

Optimizing medical document lifecycle with AI

Automate the most impactful use cases with AI as a feature

  • Automated document generation

    Automated document generation

    Create ready-to-use regulatory submissions, clinical reports, and technical documents, all while ensuring they meet compliance standards.

  • Consistency checks

    Consistency checks

    Use AI to ensure that every document adheres to your formatting and regulatory requirements, maintaining uniformity across all your documentation.

  • Regulatory compliance automation

    Regulatory compliance automation

    Automate compliance checks ensuring that your documentation is always up-to-date with the latest legal requirements.

  • Error Detection and Correction

    Error detection and correction

    Apply AI to identify and correct errors in real-time, helping you avoid costly mistakes and ensuring your documents are audit-ready.

  • AI-Assisted Review and Approval

    AI-assisted review and approval

    Streamline document approval processes, summarizing key sections and automating routine approvals.

Can AI really make a difference for medical documentation management?

Absolutely. Here’re a few concepts in our R&D that have already proven to make a significant impact:

  • AI-powered risk file generation
  • Medical literature review
  • Medical literature review
1/3
  • AI-powered risk file generation

    Challenge: In MedTech R&D, generating risk files requires filling out documents that follow strict regulatory formats, incorporating vast amount of data from clinical trials, lab results, and safety assessments. This task is time-consuming and prone to manual errors, which can delay regulatory approvals and impact compliance.

    Why it matters: Automating this process reduces the burden on your team, minimizes errors, and ensures that your risk files are ready for submission faster, helping to streamline the path to regulatory approval.

    Solution: We are developing an AI-driven system that automatically generates complex, regulatory-required risk files, ensuring that every field is accurately completed according to specific guidelines.

  • Medical literature review

    Challenge: MedTech R&D teams must consistently monitor and analyze new medical literature – often on a monthly basis – to stay informed of developments that could impact their products. This manual process is time-consuming that may lead to missed updates that could compromise product safety or regulatory compliance.

    Why it matters: Regularly updating on the latest medical literature is critical for safeguarding product safety, ensuring compliance, and staying competitive. Overlooking crucial information can result in regulatory delays, safety concerns, and lost market opportunities.

    Solution: We are building the AI solution that automates the entire literature review process, continuously scanning vast databases and extracting relevant insights, ensuring that your team is always up-to-date with the latest developments.

  • Clinical report AI automation

    Challenge: Preparing clinical trial reports in MedTech involves consolidating data from various sources such as EDC systems, lab results, and patient records. Ensuring that this data is accurately and consistently reflected across multiple documents is a labor-intensive process that may hinder regulatory submissions.

    Why it matters: Timely and accurate clinical trial reports are vital for meeting regulatory deadlines and advancing clinical trials. Any delays or inaccuracies can jeopardize the approval process and slow down the development of new therapies.

    Solution: We are developing an AI-driven auto-fill template system that accurately pre-populates clinical trial reports, minimizing manual data entry and enhancing consistency across all documents.

Your partner in AI-driven transformation, committed to advancing MedTech document management

Star AI Innovation Hub develops tailored AI solutions to streamline your MedTech documentation processes.

number 1

Pragmatic AI

We customize our AI tools to meet the unique demands of MedTech, ensuring they align perfectly with your specific documentation and compliance needs.

number 2

End-to-end support

From strategic consultation to full-scale AI implementation, we are dedicated to ensuring seamless integration, maximized ROI and adoption.

number 3

Intuitive user experience

Our AI tools are designed for ease of use, enabling your team to adopt new technologies quickly and with minimal training.

number 4

Built for compliance

Our AI-driven document generation systems are crafted with compliance at their core, ensuring your documents meet the highest industry standards every time.

We're certified and experienced healthcare technologists

Standards

  • ISO 13485
    ISO 13485
  • ISO 27001
    ISO 27001
  • IEC 62304
    IEC 62304
  • 21 CFR 820
    21 CFR 820
  • GDPR
    GDPR

Integrations

  • Cerner
    Cerner
  • Epic
    Epic
  • Allscripts
    Allscripts
  • Surescripts
    Surescripts

Technologies

  • Apple HealthKit
    Apple HealthKit
  • Validic
    Validic
  • Iguana
    Iguana
  • Mirth
    Mirth

Contact our experts

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