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AI can speed up 510(k) predicate research by 70-80%, find relevant FDA guidance in minutes instead of hours, and organize evidence trails automatically. But AI cannot make regulatory strategy decisions, replace required testing, or take accountability for submission content. Best results: Use AI for research-heavy tasks (finding predicates, FDA guidance, standards), pair with regulatory consultant for strategy and review. Cost comparison: AI tools $200-$2K/month vs. consultan

Medical device clinical trials vary widely in cost depending on device risk class, study design, patient count, duration, and endpoints . Typical total budgets range from ≈$1 M to $20 M+  for studies supporting regulatory submissions – with higher budgets common for large pivotal trials. Per-participant costs for device studies often range from about $14,000 to $50,000+ per enrolled patient  depending on complexity and follow-up. Many companies overspend because they assume c

FDA inspects medical device manufacturers to verify compliance with 21 CFR Part 820 quality system requirements , using a structured approach often associated with the QSIT  inspection method. Inspections can be routine surveillance  or for-cause , such as follow-up to significant complaints, recalls, or other risk signals. Plan 8–24 weeks  to get inspection-ready by closing CAPA gaps, organizing DHF and DMR records, confirming complaint handling, and running a mock audit. Du

Choose your sterilization method based on material compatibility first , then regulatory precedent, cost, and timeline . Ethylene oxide (EO) is the most widely used method across medical devices and works for many complex, low-temperature materials, but total turnaround often takes 1–3 weeks  including aeration. Steam sterilization is the fastest and least expensive , but only suitable for heat- and moisture-stable devices. Gamma radiation is effective for some polymers but c