regulatory agencies, in public health protection/regulationmedical device biocompatibility, body contact time/locationthin films on external, companies and ongoing researchpackaged medical devices, hemo‐/biocompatibility to sterilizationmethods, for device manufacture/processing/packing, installation...
High-end medical devices—such as software/artificial intelligence (AI)-based medical devices—continue to advance rapidly, and are now widely used in healthcare systems around the globe. Each medical device imported to China needs...
The medical products administration and the health department shall supervise and manage the quality of medical devices and the use of medical devices in the sector of using according to their respective duties. China has also established a medical device adverse event monitoring system to collect, a...
Meet medical Device translation requirements and reach authorization with our regulatory translation services.
Medical Device Market Research Projects Completed Meet NAMSA’s Team of Experts Explore the depth of our team’s expertise in biological safety, EU MDR/IVDR, FDA compliance, market research, and more. Meet All of Our Consultants Adam Saltman, PhD, MD ...
The publication of the new Medical Device Regulation MDR 2017/745 and the In Vitro Diagnostics Regulation IVDR 2017/746 in April 2017 ushered in a new era for the approval of medical devices in Europe. These regulations repealed the European Council Directives 90/385/EEC, 93/42/EEC, and 98...
This time I would like to share the importance of regulatory science in medical device development and deepen the understanding of the overall picture of regulatory science. DOI: 10.11239/jsmbe.55Annual.195 年份: 2017 收藏 引用 批量引用 报错 分享 ...
In 2017, the CMDE established the AI working group to: Learn about the regulatory control and product registration procedure for AI medical devices in other countries Knowledge sharing with related enterprises, research facilities and medical institutions to understand the AI product characteristics, techn...
"Join us at the 4th Medical Device Event"This two-day event will shed light on the most important and relevant medical device regulation topics. Through case studies, interactive presentations, and discussions, attendees will learn which regulatory strategy is applicable for their products, how to ...
The knowledge and compliance with regulatory requirement is a key to success in development and marketing of medical devices. High quality and well-designed medical devices are necessary to provide safe and effective clinical care for patients as well as to ensure the health and safety of profession...