Turn PMS from a checkbox into a system that actually runs
PMS isn't a standalone document — it's part of the quality management system, running across the full product lifecycle.
Different device classifications call for different surveillance intensity — see how PSUR, PMCF, and trend reporting connect.
Drawing on DQS audit experience, we unpack where manufacturers are most often flagged for nonconformities in PMS.
Bring your own product's questions — there's an open Q&A session during the live broadcast.
Four dimensions, one complete walk-through of PMS
How PMS fits within the QMS, covering design, production, and post-market activity as one coherent structure.
Standardized processes for complaint handling, adverse event reporting, and collecting and analyzing user feedback.
What a solid PMS Plan looks like, and how to connect it to lifecycle management from before launch.
Risk-based surveillance intensity by device classification, and how PSUR, PMCF, and trend reporting work together.
Who should attend
Lane Ji
Medical Device Business Director, DQS
Insight from real-world audit practice
Long-standing experience leading EU MDR certification audits for medical devices, with deep familiarity in post-market surveillance and clinical evaluation review priorities. Previously invited to speak at the 16th China International Medical Device Regulatory Forum (CIMDR) and other industry events.
