Risk Term

FDA 510(k) Premarket Notification

FDA 510(k) is a premarket notification required by the US FDA to be submitted before a medical device can be marketed. It must demonstrate that the device is substantially equivalent to a legally marketed predicate device. This is a critical regulatory pathway for medical device market access in the USA.

Curated by Winners Consulting Services Co., Ltd.

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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