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    • Case Study
      Medical Devices

    inne Builds Regulatory Confidence with BSI

    A women’s health innovator strengthens IVDR readiness, predictability and EU market access with BSI.

    Testimonial

    “Quality is the number one thing you should try to be predictable on for a business to flourish.” 

    Eirini Rapti Managing Director and Quality Lead, inne
    Women using interactive whiteboard.
    The People

    Innovative Women’s Health Achieves Accreditation Milestone

    inne develops hormone monitoring technology, designed to support fertility insight and serve as a certified, hormone-free contraceptive method.

    The Challenge

    Building Quality and Regulatory Confidence in a Complex Medical Device Environment

    inne needed a Notified Body that could provide IVDR certification, clear timelines and help reduce uncertainty.

    As a women’s health innovator operating in a highly regulated medical device environment, inne had embedded quality from an early stage. The company needed to transition from IVDD to IVDR while maintaining business confidence, supporting shareholders, and preparing for future international expansion. For a startup, predictability, clarity, and trusted Notified Body regulatory services were critical to sustaining momentum. 

    The Solution

    A Clear, Collaborative Certification Journey with BSI

    BSI provided technical expertise, transparent communication and Dedicated Review Service through IVDR certification, IVDD surveillance transfer, and ISO 13485 certification processes.

    inne selected BSI for its depth of medical device expertise, accessible guidance and ability to combine technical quality language with business reality. Through BSI’s Dedicated Review Service, inne gained greater predictability, direct interaction with reviewers and a scheme manager relationship that helped the team plan with confidence. BSI Dedicated Review Service supported inne’s IVDR conformity assessment application, IVDD transfer of appropriate surveillance and ISO 13485 certification within a demanding timeframe.

    The Benefits

    Predictability, Efficiency and Progress.

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    • Icon description

      BSI helped inne understand regulatory complexity into a structured pathway towards quality.

    • Icon description

      Built confidence through clear timelines and planning.

    • Icon description

      IVDR certification, IVDD transfer and ISO 13485 QMS certification.

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      Reduced uncertainty with constructive question rounds.

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      Enabled future international market planning.

    Testimonial

    “For us, BSI was one source of truth we trusted.” 

    Eirini Rapti Managing Director and Quality Lead, inne
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    Why BSI

    Trusted Expertise for Regulated Innovation

    BSI helps medical device organizations navigate complexity with clarity, credibility, and confidence.

    BSI combines technical expertise, regulatory understanding and guidance to help organizations strengthen quality systems, prepare for certification and progress with greater confidence. 

    Contact Us

    Let us help you on your certification journey

    Whether you're starting the certification process, looking to transfer or just need to discuss options for your business, we can help.

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