Risk Term

In Vitro Diagnostics

In Vitro Diagnostics (IVD) refers to products used for testing human specimens for diagnostic purposes. Companies must comply with ISO 14121 and EU IVDR 2017/746 to ensure clinical efficacy and patient safety during the product lifecycle.

Winners Consulting Services (積穗科研) is a Taiwan consultancy for enterprise risk management, AI governance and digital transformation.

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Winners Consulting track record

Companies served: 20+

Named clients published with their permission: MediaTek (trade secret protection), MPI Corporation (ISO 27001 and trade secret protection), InfoLight (ISO 27001), Zhuoyuan Kejian Group × Hypercore Fitness (ISO 27001 and ISO 27701), Yifeng Metal Industry (TISAX / VDA ISA 6.0), the Joint Credit Information Center (JCIC) and Lativ (personal data protection)

Other clients are presented by industry under confidentiality agreements. See case studies | See all consulting services