ISO 13485 has undergone its first major overhaul of manufacturing system requirements since 2003. Over the next three years, both the previous requirements and 2016 requirement will co-exist, [...]
Blog Home TAG: Medical Device
By Sal LucidoPosted
After decades spent helping companies develop and implement enterprise quality management systems, a consistent pattern has emerged in all effective system implementations. Regardless of [...]
In Medical Device Industry, FDA Regulated Industries, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk ManagementPosted
China has often faced criticism for lax regulation of drug and medical device manufacturing. In addition, long-term accusations of bribery for inspection favoritism is still a real concern. Do [...]
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