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ccc-mark-approval

Is CCC Mark Approval necessary for Medical Devices and IVD?

China Compulsory Certification (CCC) The CCC mark is the new compulsory Safety & Quality mark for many products sold on the Chinese market. CCC Mark Approval  became effective on May 1, 2002. It is the result of the recent integration of China’s two compulsory inspection systems. (One to check contents of products for import and […]
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Six Sigma – Healthcare

What is Six Sigma? Six Sigma is a process improvement initiative used to eliminate defects from processes. The goal is to create near perfection through continuous improvement that aligns the “voice of the process” with the “voice of the customer”. No more than 3.4 defects per one million opportunities (DPMO) is the goal of Six […]
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Reliability

Product Design Reliability Reliability Engineering, Risk & Productivity The FDA and other regulatory agencies do not regulate “reliability engineering” or “productivity” as standalone disciplines. Instead, they expect evidence that devices are reliable, risks are controlled, and processes are effective—and they enforce this through design controls, risk management, CAPA, and production controls. Reliability Engineering “Can you […]
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