ISO/DIS 18969: A Process-Based Approach to Clinical Evaluation (What It Changes) скачать в хорошем качестве

ISO/DIS 18969: A Process-Based Approach to Clinical Evaluation (What It Changes)

Clinical evaluation shouldn’t be a “last-minute CER scramble.” ISO/DIS 18969 reframes clinical evaluation as a continuous, collaborative process that starts at the beginning of design and development—and evolves through the full device lifecycle. In this Friday In-Focus session, Danielle Giround (Convener, ISO TC194 WG4) and Maria E. Donawa (Donawa Lifescience; clinical evaluator and longtime standards contributor) explain the philosophy behind ISO/DIS 18969, the four-phase lifecycle model (early, mid, late development + post-market), and why cross-functional collaboration (clinical, risk, RA, design, PMS) reduces late-stage surprises and improves evidence quality. You’ll learn what ISO/DIS 18969 does—and does not—require, how it can support MDR without adding unnecessary burden, how it connects to ISO 13485 design controls and ISO 14971 risk management, and what manufacturers can start doing now before the standard is published. Speakers: • Danielle Giround — Convener, ISO TC194 WG4 (ISO/DIS 18969) • Maria E. Donawa — Donawa Lifescience; clinical evaluator and ISO TC194 WG4 member Hosted by Sean Smith (MedTech Leading Voice / MLVx) Key takeaways: • Clinical evaluation as a process, not a document • Four phases across the lifecycle, with iteration and feedback loops • Documentation flexibility (use your existing templates; document “what,” not “how”) • Stronger linkage between clinical data and risk control verification • Better alignment of regulatory strategy + clinical evidence generation • Timeline to publication: comments in March → FDIS by Aug 17 → target publication ~October Timestamps 00:05 – Danielle intro + why ISO/DIS 18969 has been a “rocky road” 02:13 – The core idea: clinical evaluation starts early (process, not document-writing) 03:13 – Integrated collaboration model: clinical, design, risk, RA, PMS (no silos) 05:16 – Four phases: early, mid, late development + post-market 08:15 – Iteration over time: design inputs ↔ early clinical evaluation planning 10:16 – Document flexibility: what to document (not rigid templates) 12:15 – Early literature searches: systematic, but less formal than final appraisal 15:13 – Transferability discussion (without using “equivalence”) + special device considerations (SaMD/AI) 18:43 – Poll + certificate notes 19:27 – Maria perspective: why the process framing matters (and common real-world problems) 25:21 – How ISO 13485 design controls support early clinical evaluation integration 35:50 – ISO 14971 risk management: linking clinical data to risk control verification 40:14 – Regulatory strategy alignment + methodological quality and scientific validity 44:31 – What manufacturers can do now (before publication) 46:24 – Timeline: FDIS by Aug 17 → publication targeted ~October 47:54 – Will FDA “adopt” ISO 18969? (process guide, not new regulation) 51:08 – Why CE/CER work is often late + how this process improves efficiency 55:15 – Does ISO 18969 add MDR requirements? (No—clarifies process) 56:13 – Early search documentation tips 57:55 – Closing remarks + recording/slides notice