F.L.Y Healthcare

AI-Powered · EU Medical Device Compliance

Let AI accelerate your path to EU compliance

F.L.Y is building an AI assistant for EU medical device compliance — from product classification and technical file review to project management, AI compresses days of compliance work into hours, with senior regulatory experts overseeing every step.

Contact us Explore the capabilities

Launching soon. Contact us to learn more or discuss your compliance needs.

Bringing medical devices to Europe — where does it slow down?

Traditional compliance relies heavily on manual work: slow, error-prone, hard to track.

  1. 01

    Slow classification

    Manually checking MDR and judging risk class often takes 2–5 days per product.

  2. 02

    Heavy file review

    Technical files, declarations of conformity, risk reports pile up; manual review is exhausting.

  3. 03

    Fast-changing rules

    MDR / IVDR keep evolving; a moment's inattention means breaching a new requirement.

  4. 04

    Invisible progress

    Projects tracked by email and Excel; clients don't know where things stand or what's missing.

What the AI Assistant can do for you

Six capabilities covering the full compliance chain — from enquiry to maintenance. AI accelerates, experts validate.

01

Smart Classification & Compliance Assessment

Upload product information and AI quickly proposes an initial classification (e.g. Class IIa), the regulatory basis, and a compliance roadmap — confirmed after expert review.

What once took 2–5 days, AI drafts in hours.

02

AI Technical File Review

Upload technical file PDFs and AI automatically checks for missing items (e.g. manufacturer address, UDI), flags outdated regulatory references (e.g. still citing the repealed MDD), and assists with multilingual label consistency checks.

03

Regulatory Knowledge Q&A

Built on a knowledge base of EU MDR / IVDR / MDCG guidance / ISO standards — ask anytime, and AI answers with cited provisions to help you understand requirements fast.

04

Smart Enquiry Entry

Ask questions anytime via the website, email and other channels; AI first gives an initial direction and a checklist of required documents, then a consultant takes over the details — around the clock.

05

End-to-End Project Management

An online project board tracks every stage; AI automatically flags missing materials and sends reminders, keeping progress and to-dos clear at a glance.

06

Real-Time Regulatory Monitoring

AI continuously scans EU regulations and notified-body announcements; when a change affects your product, it proactively notifies you and advises whether a file review is needed.

How you'll use the assistant

From question to market entry, a clear self-serve path — with experts validating at every key milestone.

  1. 01

    Ask

    Ask the AI about your product and target market, and get an initial compliance direction.

  2. 02

    Upload

    Upload product manuals, technical specifications and existing certifications.

  3. 03

    Assess

    AI drafts a classification and compliance roadmap; experts review and confirm.

    Expert validation
  4. 04

    Review

    AI reviews your technical files and points out missing items and outdated references.

  5. 05

    Plan

    Receive a compliance service plan with a clear scope and next steps.

    Expert validation
  6. 06

    Progress

    A project board tracks progress; the system automatically reminds you to submit materials.

  7. 07

    Maintain

    The assistant continuously monitors regulatory changes and proactively helps you stay compliant.

Why choose the AI Assistant

Faster preparation and clearer progress, with expert confirmation where it matters.

DimensionTraditional manual processF.L.Y AI Assistant
Classification2–5 daysAI drafts in hours, expert confirms
File reviewManual, file by fileAI pre-screens, expert validates
Project trackingEmail / ExcelOnline board, auto reminders
Regulatory updatesRely on staff to noticeAssistant monitors and notifies
AvailabilityBusiness hoursEnquiry entry available 24/7

Who it's for

Designed for organisations managing demanding European medical-device compliance work.

01

Chinese / East Asian medical device manufacturers

Entering the European market, needing full MDR / CE support.

02

EU Authorized Representatives / CE consultancies

Wanting to boost compliance efficiency with AI.

03

Medical device export service providers

Handling compliance across many clients and projects.

Coming soon

Discuss your compliance needs with our team

F.L.Y Healthcare GmbH
business@fly-healthcare.com
Am Müllerkamp 15, 32257 Bünde, Germany