Medical device companies must comply with FDA requirements to address quality issues through a complex and sometimes inefficient process called CAPA. One such company applied Six Sigma to the CAPA process to significantly reduce rework loops, reduce cycle time and reduce time to resolve rejections.
ReAgent Achieves ISO 13485 Accreditation for Medical Devices & Launches New Biological Reagent Manufacturing Service
ReAgent Chemical Services has successfully achieved ISO 13485 accreditation. On 8th August 2019, they were awarded this international ISO standard which demonstrates that they meet the rigorous requirements of a quality management system specific to the medical devices industry.
The life sciences industry, which includes the production of pharmaceuticals and medical devices, faces unique challenges that have made it a late adopter of continuous improvement techniques such as Lean Six Sigma (LSS). Most critical are severe government regulation, product approval phases that can span multiple years, and the imperative responsibility to ensure patient safety…