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Iso 13485 2016 Medical Devices Articles & Analysis
4 articles found
Quality issues in medical devices often point to underlying weaknesses in the system, and ISO 13485-compliant CAPA is essential for correctly identifying cause and preventing the problem from recurring. Here’s an overview of CAPA requirements in ISO 13485 for medical device ...
It is an undeniable fact that safety and quality are the top-most priority for medical device companies. However, the best-practices to maintain these priorities are defined under ISO 13485. You cannot brush aside the need for implementing the right enterprise quality management software to create and maintain the culture of quality and continuous improvements. The software may help you meet ...
Safety is absolutely paramount in the medical industry, with lives literally at stake if something were to go wrong. Regrettably, this was more than reinforced recently following the tragic news of a death of a newborn at a hospital in Sydney, Australia, after it was mistakenly administered nitrous oxide (N2O) instead of oxygen (O2) in July this year. A tragic occurrence of similar ...
Safety is absolutely paramount in the medical industry, with lives literally at stake if something were o go wrong. Regrettably, this was more than reinforced recently following the tragic news of a death of a newborn at a hospital in Sydney, Australia, after it was mistakenly administered nitrous oxide (N2O) instead of oxygen (O2) in July this year. A tragic occurrence of similar circumstance ...