Manufactured by
Ramboll Deutschland GmbH
Hamburg, Germany
Ramboll is a global engineering, architecture and consultancy company with more than 18,000 experts that create sustainable solutions across energy, real estate, transport, water, waste, industry, finance, technology, healthcare and public sectors. Ramboll combines deep scientific expertise and technical acumen with a broad global footprint to deliver sustainable solutions helping our clients around the world to address some of the most challenging environmental and human health issues. Reputation for technical and scientific excellence, innovation and client service Deep scientific expertise and technical acumen Private and public sector clients around the world Extensive experience in the Americas, Europe, Africa and Asia Pacific Our services for medical device manufacturers include: international market access strategies; globally compliant quality management systems; MD (EU) 2017/745 and IVDR (EU) 2017/246 compliance services; risk management according to ISO 14971; biocompitability in line with ISO 10993; expert advice on dealing with critical substances; clinical evaluation and literature research; qualification and validation. Visit us at the joint stand of Innovative health technology Rhineland-Palatinate MEDICA 2025 – Stand E92/ Hall 3 .
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Ebitmed Information Technology (Shanghai) Co., Ltd. · China
Medical device evaluation services providing systematic assessment, regulatory compliance review, and clinical validation support for medical devices and IVDs. Services include safety and efficacy evaluation, standards compliance verification, and documentation support to facilitate market entry and regulatory approval.
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Medical device safety evaluation services for regulatory compliance and risk assessment. Provides comprehensive testing, biocompatibility analysis, and standards compliance documentation to support market approval and device certification across global markets.
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Engineering and regulatory consulting for safety-critical medical device development, including system architecture design, quality management, regulatory affairs support, and comprehensive testing and optimization services.
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