Punyam Academy is very excited to introduce the ISO 13485 QMS foundation training course. The ISO 13485 QMS Foundation Training will benefit for the attendees to understand the ISO 13485 medical ...
This course is based on the 2016 version of the ISO 13485 Standard, providing skills necessary to perform internal process audits in the medical device industry. It features a detailed review of the ...
This course is based on the 2016 version of the ISO 13485 Standard, providing skills necessary to perform internal process audits in the medical device industry. It features a detailed review of the ...
Following the new outcome meeting statement posted Monday by the management committee of the International Medical Device Regulators Forum (IMDRF), Focus obtained insights into upcoming revisions to ...
The medical device sector must meet stringent regulatory requirements plus convince potential customers that they make reliable, safe products. Having a strong commitment to quality can help customers ...
The three-year transition period of ISO 13485:2016 officially comes to an end this month, but that deadline is almost meaningless at this stage. If you’re a medical device OEM doing business ...
Jianyuan (Yuan) Hua, FDA Regulatory and Compliance Associate in New York, contributed to the drafting of this post. The U.S. Food and Drug Administration (FDA) issued the much-anticipated proposed ...
ISO 13485:2016 is designed to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent ...
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