https://dpdynamicsol.com/insights/ Practical guidance on quality management systems, risk management, and statistics for combination products and medical devices. Written for quality, regulatory, and R&D teams in medtech. en-us Copyright 2026 DP Dynamic Solutions info@dpdynamicsol.com (David Plescia) info@dpdynamicsol.com (David Plescia) Fri, 07 Aug 2026 00:00:00 +0000 Fri, 07 Aug 2026 11:45:39 +0000 DP Dynamic Solutions feed generator https://www.rssboard.org/rss-specification https://dpdynamicsol.com/insights/process-capability-cpk-ppk.html https://dpdynamicsol.com/insights/process-capability-cpk-ppk.html Fri, 07 Aug 2026 00:00:00 +0000 Statistics A capability index is a single number that compresses an entire process into a verdict. That is what makes it useful, and what makes it so easy to misuse. Most capability findings are not about the arithmetic — the arithmetic is trivial. They are about everything that should have been established before anyone computed it. https://dpdynamicsol.com/insights/qmsr-transition-iso-13485.html https://dpdynamicsol.com/insights/qmsr-transition-iso-13485.html Mon, 15 Jun 2026 00:00:00 +0000 Quality Systems The FDA's Quality Management System Regulation replaces the bulk of the old Quality System Regulation by incorporating ISO 13485:2016 directly into 21 CFR Part 820. If your quality system was already built to ISO 13485, the change is smaller than you fear. If it was built to the old Part 820 clause structure, the work is real — but it is mostly mapping, terminology, and records, not a rebuild. https://dpdynamicsol.com/insights/sample-size-justification-design-verification.html https://dpdynamicsol.com/insights/sample-size-justification-design-verification.html Wed, 20 May 2026 00:00:00 +0000 Statistics "We tested thirty units" is a sample size. It is not a justification. The question a reviewer or auditor is really asking is: what claim are you making about the population, and with what confidence? Answer that, and the number falls out of the arithmetic instead of out of habit. https://dpdynamicsol.com/insights/21-cfr-part-4-combination-product-quality-system.html https://dpdynamicsol.com/insights/21-cfr-part-4-combination-product-quality-system.html Tue, 28 Apr 2026 00:00:00 +0000 Combination Products A prefilled syringe is not a drug that happens to ship in a device, nor a device that happens to contain a drug. It is one product that must satisfy two bodies of cGMP. Part 4 exists so you can meet both obligations with a single, coherent quality system instead of two that argue with each other. https://dpdynamicsol.com/insights/iso-14971-risk-management-file-audit.html https://dpdynamicsol.com/insights/iso-14971-risk-management-file-audit.html Tue, 17 Mar 2026 00:00:00 +0000 Risk Management Risk management files rarely fail because the team misjudged a hazard. They fail because the file cannot demonstrate that a process happened. An auditor is not primarily assessing whether your risk estimates are correct — they are testing whether the reasoning is complete, traceable, and still alive.