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This web site had the following on the web page, "Helping you jump your highest regulatory hurdles." We noticed that the web page said " We strive to provide our clients the expertise they need in a manner that we would expect it to be provided to us." It also said " Welcome to NJK Associates. NJK and Associates was founded in 2006 when Natalie Kennel, RAC, ASQ CQE and CQMgr recognized an unmet need in the medical device community QARA help from industry experts willing to get their hands dirty. Our Name, Our Logo, Our Passion. Every so often in life one comes across truly exc." The header had 21 cfr 820 preamble 21 cfr 820 part 11 21 cfr 820 training 21 cfr 820 definitions 21 cfr 820 capa 21 cfr 820 recall 21 cfr 820 document control 21 cfr 820 audit checklist design controls design controls fda design controls for medical devices design controls training design controls and risk management supplier audit checklist supp as the highest ranking optimized keyword.