Multi‑Level Regulatory Readiness Framework — Medical Devices (RRL‑QMS)

Executive summary

• Defines a staged nine‑level QMS readiness ladder mapped to regulatory expectations.
• Connects readiness level to approval probability via a calibrated logistic regression model (method described).
• Includes a references section anchored on primary regulatory and standards sources.

Public material is outcome-focused. Implementation details are shared only under private detail sharing (private agreement / limited scope / selective sharing).

Integrity

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How to cite

Cite as: A Multi-Level Regulatory Readiness Framework (RRL‑QMS) and Predictive Modelling for Quality Maturity in Medical Device Approvals. Zenodo. https://doi.org/10.5281/zenodo.15468504.

BibTeX:

@misc{rrlqms2025,
  title        = {A Multi-Level Regulatory Readiness Framework (RRL-QMS) and Predictive Modelling for Quality Maturity in Medical Device Approvals},
  author       = {Zadehnour, Mehdi},
  year         = {2025},
  publisher    = {Zenodo},
  doi          = {10.5281/zenodo.15468504},
  url          = {https://doi.org/10.5281/zenodo.15468504}
}