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    Medical device professional examining equipment in a cleanroom using a magnifying inspection system.
    • Case Study
      Medical Devices

    Teknimed: Early MDR Certification Through Clear Communication and Structure

    How Teknimed worked with BSI to achieve early MDR transition while maintaining operational continuity and supporting growth.

    Download the full case study
    Customer Perspective

    “Working alongside BSI demonstrates the power of trust, collaboration, and expertise.” 

    Carole Léonard President & CEO, Teknimed
    Exterior of the Teknimed building with illuminated company logo against a blue sky.
    About Teknimed

    Global medical device manufacturer with an international footprint

    Teknimed supports customers worldwide through its own orthopaedic solutions and private-label manufacturing.

    Teknimed specializes in orthopaedic solutions including bone cement, bone substitutes and polymers. Founded over 35 years ago and led by CEO Carole Leonard since 2011, it has grown from €6.5 million turnover and 35 employees to €21 million and 100 employees. It also manufactures under private-label agreements for leading global orthopaedic companies, remaining the legal manufacturer while supporting their products across international markets.

    The Challenge

    Managing MDR complexity while maintaining business continuity

    Teknimed needed to transition its portfolio to MDR while managing regulatory complexity, operational change, and continued market supply.

    Teknimed set an ambition to be among the first manufacturers to transition its full portfolio to MDR. The company faced complex regulatory requirements across its product classifications, increased documentation, and significant demands across R&D, clinical, regulatory, and quality teams. At the same time, it needed to maintain supply while transferring production between facilities and building new clean rooms.

    The Solution

    A proactive MDR strategy supported by structured communication

    Early engagement with BSI helped establish a structured approach to MDR certification and continuous improvement.

    Teknimed selected BSI early and committed to MDR compliance from the outset. It prioritized its most complex products first to accelerate learning and reduce downstream risk, brought clinical, R&D, regulatory, and quality teams together, and used a PMO structure to maintain timelines and coordination. Close engagement with BSI’s Scheme Manager and reviewers supported interactive review cycles, with key learnings applied to subsequent submissions.

    Maintaining momentum through regulatory change

    A structured MDR conformity assessment approach strengthened compliance while supporting continuity and international opportunities.

    Glass ampoules being heat-formed on automated manufacturing equipment.
    • Icon description

      Achieved early MDR compliance for Class III and wider product portfolios.

    • Icon description

      Strengthened cross-functional regulatory coordination.

    • Icon description

      Maintained supply through facility transfer and operational expansion.

    • Icon description

      Increased confidence among major global partners.

    Teknimed at a glance

    A snapshot of Teknimed’s growth, international reach, and regulatory progress.

    • €21m turnover

      Up from €6.5m.

    • 100 employees

      Growth from 35.

    • 80% international

      80% of Teknimed’s business is conducted internationally.

    • Under 1 year

      Regulatory approval facilitated in Korea in under one year.

    Customer Perspective

    “Together, we turned regulatory complexity into an opportunity for improvement and growth.” 

    Carole Léonard President & CEO, Teknimed
    Two colleagues in discussion at a desk with laptops in a bright office.
    Why BSI

    Supporting clarity, confidence, and continuity

    Technical expertise and structured communication for complex regulatory journeys.

    Teknimed highlights BSI’s deep regulatory expertise and global recognition, clear, constructive, and responsive communication, collaborative approach, early guidance materials, and continuity of engagement throughout the certification lifecycle. This helped Teknimed navigate complexity with confidence and maintain momentum throughout a demanding transition.

    Why choose BSI
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