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: Life Sciences
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
First quarter 2017 Food and Drug Administration (FDA) warning letters emphasize a lack of effective document control system compliance. Two recent warning letters are patent examples. Both [...]
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