YourEsafe

We guarantee you secure access to up to date technical records for all HL Technology products.

YourEsafe

  • Security

    Located on an encrypted cloud , accessible only by the customer and the notified body

  • Quality

    ISO 13485: 2016 Certified

    Compatible EU 2017/745 MDR regulation

  • Regulation

    A software solution that integrates all documentary needs in compliance with MDR (medical device regulation) requirements.

  • Contents

    - Production diagrams
    - Maps
    - BOM
    - Material certificates
    - Biocompatibility tests
    - Risk analysis
    - Process validations
    - Control plans
    - Measurement reports

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