Medical device manufacturing

Understand Chinese Overseas Innovative Medical Devices Regulations And Speed Up Entering Into China Market

Retrieved on: 
Tuesday, April 9, 2019
Medical device manufacturing, Medical device, CE marking, Articles, Products, Medicine, Pharmaceuticals policy, Medical writing, Biomedical engineering

The audiences of this guidebook are overseas medical device manufacturers wishing to enter into the Chinese medical device market, and multinational medical device companies have penetrated into the Chinese medical device market, and their senior executive officers engaging in regulatory affairs expecting to understand how to apply for registration of their medical device products in China and how to comply with the latest Chinese regulations for medical device registration.

Key Points: 
  • The audiences of this guidebook are overseas medical device manufacturers wishing to enter into the Chinese medical device market, and multinational medical device companies have penetrated into the Chinese medical device market, and their senior executive officers engaging in regulatory affairs expecting to understand how to apply for registration of their medical device products in China and how to comply with the latest Chinese regulations for medical device registration.
  • After having skimmed through this guidebook, audiences can clearly acquire not only a comprehensive knowledge of the latest Chinese special examination and approval of overseas innovative medical devices but also the practical operation how to comply with the latest Chinese special examination and approval of overseas innovative medical devices.
  • "Latest Guidebook for Chinese Special Examination and Approval Procedures for Innovative Medical Devices (2019 Edition): speed up overseas innovative medical devices entry into Chinese market"provided a comprehensive knowledge of the latest Chinese special examination and approval procedures for innovative medical devices to guide your practical operation how to comply with the Chinese regulations.
  • It is an essential resource for overseas and multinational medical device manufacturers to speed up overseas innovative medical devices entry into Chinese market, which provides not only a comprehensive knowledge of the latest Chinese special examination and approval procedures for innovative medical devices but also the practical operation how comply with the latest Chinese regulations to smoothly navigate complex regulatory requirements.

Understand Chinese Overseas Innovative Medical Devices Regulations And Speed Up Entering Into China Market

Retrieved on: 
Tuesday, April 9, 2019
Medical device manufacturing, Medical device, CE marking, Articles, Products, Medicine, Pharmaceuticals policy, Medical writing, Biomedical engineering

The audiences of this guidebook are overseas medical device manufacturers wishing to enter into the Chinese medical device market, and multinational medical device companies have penetrated into the Chinese medical device market, and their senior executive officers engaging in regulatory affairs expecting to understand how to apply for registration of their medical device products in China and how to comply with the latest Chinese regulations for medical device registration.

Key Points: 
  • The audiences of this guidebook are overseas medical device manufacturers wishing to enter into the Chinese medical device market, and multinational medical device companies have penetrated into the Chinese medical device market, and their senior executive officers engaging in regulatory affairs expecting to understand how to apply for registration of their medical device products in China and how to comply with the latest Chinese regulations for medical device registration.
  • After having skimmed through this guidebook, audiences can clearly acquire not only a comprehensive knowledge of the latest Chinese special examination and approval of overseas innovative medical devices but also the practical operation how to comply with the latest Chinese special examination and approval of overseas innovative medical devices.
  • "Latest Guidebook for Chinese Special Examination and Approval Procedures for Innovative Medical Devices (2019 Edition): speed up overseas innovative medical devices entry into Chinese market"provided a comprehensive knowledge of the latest Chinese special examination and approval procedures for innovative medical devices to guide your practical operation how to comply with the Chinese regulations.
  • It is an essential resource for overseas and multinational medical device manufacturers to speed up overseas innovative medical devices entry into Chinese market, which provides not only a comprehensive knowledge of the latest Chinese special examination and approval procedures for innovative medical devices but also the practical operation how comply with the latest Chinese regulations to smoothly navigate complex regulatory requirements.

2-Day Seminar: FDA Approval Process for Medical Devices (London, United Kingdom - September 17-18, 2019) - ResearchAndMarkets.com

Retrieved on: 
Monday, January 28, 2019
Health, Medical devices, Health, Food and Drug Administration, Articles, Medical device, Medical equipment, Pharmaceutical industry, Medical technology, Medical device manufacturing, Office of In Vitro Diagnostics and Radiological Health

The "FDA Approval Process for Medical Devices" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "FDA Approval Process for Medical Devices" conference has been added to ResearchAndMarkets.com's offering.
  • This seminar will provide a solid foundation in the approval and clearance processes for medical devices in the United States.
  • Participants will gain an understanding of the underlying legal and regulatory requirements and the general controls applicable to all devices, including device classification, establishment registration and device listing.
  • Participants will also learn about the pre-submission process, which FDA strongly recommends prior to the initial submission of novel devices to help ensure a successful submission process.

Maxim Delivers Industry's First Radiation-Tolerant Secure Authenticator Designed to Withstand Harsh Environments to Protect Medical Device Data

Retrieved on: 
Wednesday, July 11, 2018
Medicine, Medical technology, Health, Medical equipment, Hygiene, Medical devices, Microbiology, Sterilization, Medical device manufacturing, Medical device, Surgery

Medical device manufacturers commonly sterilize limited-use surgical tools or sensors through a gamma or e-beam process.

Key Points: 
  • Medical device manufacturers commonly sterilize limited-use surgical tools or sensors through a gamma or e-beam process.
  • This can jeopardize medical device data and patient safety, both of which are of critical importance for medical device manufacturers.
  • The DS28E83 secure authenticator integrates a radiation-tolerant NVM to prevent data loss during sterilization.
  • With this capability, device designers can implement cost-affordable protection from unauthorized re-use and aftermarket device counterfeiting.