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Regulatory Compliance

Emergo webinar - medical device design controls January 2019
January 31, 2019; 9am CST In fulfilling their regulatory obligations, manufacturers face many challenges, including establishing and implementing processes for design, production, purchasing, competency, validation, CAPA, and many others. Among these, the design and development process is key to successfully ensuring patient safety. Understanding user needs is a foundational step in the design and development process as well as any risk management effort. Once identified, user needs become design input requirements, which are translated into design output requirements that can take many forms...
Learn about the Japanese PMDA regulations which apply to medical devices
The following documents were published by Japan's Ministry of Health, Labour and Welfare (MHLW) or the Pharmaceutical and Medical Devices Agency (PMDA) and are in PDF format.
Learn about the Chinese CFDA regulations which apply to medical devices
Shown below are some important regulatory documents impacting medical device companies. Unfortunately, the NMPA only makes these available in Chinese.
Learn about the Chinese CFDA regulations which apply to medical devices
以下列出中国国家食品药品监督管理局(CFDA)对於医疗器械公司会造成重大影响的文件,不过所提供的文件都只限於中文版。
Learn about the Health Canada regulations which apply to medical devices
We have assembled the following documents about Medical Device Regulations from Health Canada as a service to the medical device community.
Learn about the Health Canada regulations which apply to medical devices
下列文档是加拿大卫生部医疗器械相关规定,也是我们能够提供的服务。