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 CATEGORY: FDA Regulated Industries
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 [...]
By Eric Cooper
In eMDR, Medical Device Industry, FDA Regulated Industries, Pharmaceutical Industry, Quality Management, Regulatory Compliance ManagementPosted
The simple fact is that no enterprise QMS software will ever meet 100% of a company’s needs “as is.” Experience shows that unless you’re a small business with limited resources, you can’t work [...]
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