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英文字典中文字典相关资料:


  • Overview of Device Regulation | FDA
    Overview of regulations for medical devices: premarket notifications (510(k)), establishment registration, device listing, quality systems, labeling and reporting requirements Device Advice
  • FDA Regulation of Medical Devices - Congress. gov
    Under the Federal Food, Drug, and Cosmetic Act (FFDCA), all medical device manufacturers must register their facilities and list their devices with FDA and follow general controls requirements FDA classifies devices according to the risk they pose to consumers The FFDCA requires premarket review for moderate- and high-risk devices
  • From Concept to Compliance: Regulatory Affairs for Medical Devices
    In the US, the Food and Drug Administration (FDA) oversees the regulation of medical devices under the Federal Food, Drug, and Cosmetic Act (FD C Act) The FDA classifies medical devices into three classes based on risk, from Class I (low risk) to Class III (high risk)
  • Overview of FDA Regulation of Medical Devices (FDA 101)
    On February 23, 2022, FDA published a proposed regulation to amend the device current good manufacturing practice requirements of the QS Regulation to incorporate the international standard specific for medical device quality management systems set by the International Organization for Standardization (ISO), ISO 13485:2016 Medical devices – Qual
  • GENERAL OVERVIEW Regulatory FDA Medical Device Best Practices Guide
    The FDA’s Medical Device Safety Action Plan, published in April 2018, is designed to protect patients and to enhance the development of safe, innovative medical devices that address unmet clinical needs The FDA has multiple authorities to regulate the use and marketing of medical devices following approval or clearance
  • FDA Approval Process for Medical Devices: Step-by-Step Guide
    Here is a complete overview of the FDA certification process for medical devices: Identify a predicate device for comparison and create a comparison chart Determine your device’s correct risk class and whether it falls under the FDA 510 (k) pathway
  • US Medical Device Regulations via the FDA - RegDesk
    The United States Food and Drug Administration regulates medical devices See what is regulated, the classification systems and outline of the approval process
  • FDA Regulations For Medical Devices: An Overview - Compliance Gate
    In this guide, we introduce you to lab testing requirements, classification, device registration, labeling, GMP and premarket submissions Mentioned Products First of all, importers shall determine the classification of their medical device, which is based on the device description, intended use, and risk associated with the devices
  • MEDICAL DEVICES: FDA regulatory pathways for medical devices - TOPRA
    new medical devices to the US market: the PMA, the 510(k), the De Novo, and the Humanitarian Device Exemption (HDE) pathways • The US FDA requires all medical device manufacturers to register their facilities, and list their devices with the agency • Once a medical device is on the US market, the manufacturers must
  • An Introduction to FDA’s Regulation of Medical Devices
    • Explain FDA’s role in regulating medical devices • Define a medical device and review basics about device classification • Describe five steps to get a new product to market





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