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.
The EU Medical Devices Regulation (MDR 2017/745) emphasizes Post-Market Clinical Follow-up (PMCF) studies for collecting structured post-market data about your device. A PMCF study examines how your device performs when used as intended to gain verification of the clinical performance of your product and to collect safety information.
The Final Draft International Standard (FDIS) of the 3rd Edition of ISO 14971 is now in its final stages and is expected to be published in August of 2019.
これまで欧州で
欧州委員会の 新たな体外診断用医療機器規則(IVDR 20
It has been one year since the FDA released the latest Guidance Document pertaining to managing Cybersecurity in Medical Devices. What impact is this guidance having on medical device manufacturers and how are they handling pre-market submissions?
의료기기 등록 요건에 적용되었던 일본 약사법(PAL)이 2014년 11월, 의약품 및 의료
드디어 시행됩니다.
유럽의 의료기