医療機器関連サービス
医療機器関連サービス
UL Solutionsは、医療機器及び体外診断用医療機器、ラボ機器/検査・測定機器の製造者に対して、製品安全規格、EMC規格に準じた評価試験及び認証、生体適合性試験、再処理バリデーション、包装バリデーション、およびISO 13485審査登録サービスを提供しています。お客様の薬事申請に必要な電気安全試験、Software、Cybersecurity及び生体適合性試験につきまして、IEC、ISO規格等に基づく試験レポートをご提示しておりますので、どうぞお気軽にお声かけください
1～7 件を表示 ／ 全 7 件
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Testing and evaluation services related to medical devices
Providing solutions for the global market.
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Medical Device EMC Testing Services
Manufacturers need to demonstrate compliance with regulations regarding safety and performance requirements to ensure product safety and market entry.
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Medical device product safety standards evaluation, testing, and certification services.
Compliance with IEC 60601, IEC 61010, and various individual standards.
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IEC 62304 Software Evaluation Services
As an IAS ISO/IEC 17025 accredited testing laboratory for IEC 62304, we provide evaluation services for embedded software.
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Biological evaluation and biocompatibility testing services
In addition to the ISO 10993 series, it is possible to comply with FDA guidance, Ministry of Health, Labour and Welfare guidelines, and the United States Pharmacopeia (USP).
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Biological safety testing (ISO 10993-1, FDA, USP)
Able to respond to pharmaceutical applications in various countries.
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[Free Online Seminar] Electromagnetic Interference/EMC Testing of Medical Electrical Equipment
We will explain an overview of IEC 60601-1-2, including electromagnetic interference testing and changes from the 4th edition to the 4.1 edition.
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