This white paper will discuss the requirements for achieving compliance with the Quality Management System (QMS) regulations as they apply in Canada for obtaining a Medical Device License (MDL) under the Medical Device Single Audit Program (MDSAP).
Ken Pilgrim, P.Eng. is a Director of RA/QA for Emergo and is located in Canada. With more than 20 years of experience in quality management, his expertise includes ISO 13485, CMDR implementation and audits, and medical device registration submissions in Canada, the EU, and US.
自新欧盟医疗器械法规MDR (Medical Device Regulation 2017/745) 申请日期起,欧盟医疗器械监管当局就发布了一系列新文件及相关支持服务,旨在帮助医疗器械制造商适应新法规变更后的法规环境。 对此,作为在全球范围内经验丰富的医疗器械及IVD器械市场合
阅读更多2022年11月23-25日,2022年度医疗器械行业盛会CMEF(中国国际医疗器械博览会)在深圳落下帷幕。展会期间,美国驻广州总领事馆、美国驻上海总领事馆携手国药励展于11月25日成功举办线上“中美医疗健康产业投资研讨会”,共享2022美国前沿医疗健康产业发展趋势及最新法规合规资讯。
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