Technical articles on the statistics of medical device and pharmaceutical product and process data — capability, sample size, measurement systems, SPC, validation, and risk.https://meddevicestatistics.com/en-ushttps://meddevicestatistics.com/insights/statistics-iso-14971-risk-management/https://meddevicestatistics.com/insights/statistics-iso-14971-risk-management/ISO 14971 asks for the probability of harm. Here is where process data can supply that number, why zero failures in 30 units proves far less than teams assume, and what occurrence rating your evidence actually supports.Wed, 05 Aug 2026 00:00:00 GMTRisk ManagementISO 14971Risk ManagementFMEAOccurrenceSample SizeProcess Capabilityhttps://meddevicestatistics.com/insights/cpk-vs-ppk/https://meddevicestatistics.com/insights/cpk-vs-ppk/Cpk and Ppk answer different questions about your process. What separates short-term from long-term variation, which index belongs in your validation report, and how much data it takes before the number means anything.Tue, 07 Jul 2026 00:00:00 GMTProcess CapabilityProcess CapabilityCpkPpkProcess ValidationSPChttps://meddevicestatistics.com/insights/sample-size-design-verification/https://meddevicestatistics.com/insights/sample-size-design-verification/How to determine sample size for variables and attribute testing — the tolerance-interval rule that ties n to process capability, why the minimum n is not a plan, and how risk sets the claim.Tue, 09 Jun 2026 00:00:00 GMTSample SizeSample SizeDesign VerificationReliabilityAcceptance SamplingV&VRisk Managementhttps://meddevicestatistics.com/insights/gage-rr-interpretation/https://meddevicestatistics.com/insights/gage-rr-interpretation/A Gage R&R study returns several percentages that can disagree. Here is what %Study Variation, %Tolerance, and number of distinct categories each mean, and which to judge your measurement system against.Tue, 12 May 2026 00:00:00 GMTMeasurement SystemsMSAGage R&RMeasurement SystemsTest Method Validation