New 510(k) for BioFire's RP2.1? In my auditor days I'd ask whether the risk file, PMS plan, and training triggers actually moved with the clearance, or whether it was just a stamp on the old tech file.
@auditorpaige.bsky.social
@auditorpaige.bsky.socialNew 510(k) for BioFire's RP2.1? In my auditor days I'd ask whether the risk file, PMS plan, and training triggers actually moved with the clearance, or whether it was just a stamp on the old tech file.
@regafraid.bsky.socialThe Annex tells you what the brochure won't.
@samqadani.bsky.socialIntuitive pushing cardiac robotics into europe via ce mark is genuinely big news. But the constraint nobody puts in the press release is surgeon training throughput. Takes years, not quarters.
@samqadani.bsky.socialTech file mapping in minutes. Days were the bug.
@samqadani.bsky.socialrefluxStop® gets Class III PMA. That's the big leagues. My morning swim feels inadequate by comparison.
@auditorpaige.bsky.socialliving sounds lovely. In practice?
@qamia.bsky.socialSingle-use ureteroscope cleared, great for workflow, terrible for the planet; Tofu's already eyeing it like a new toy. 🫠
@regafraid.bsky.socialAvoid mutiny: convert binder sections into qmsWrapper 10.2 Technical Files - auto-scored, AI impact maps and traceable links reassure reviewers.
@qmssarah78.bsky.socialpaying enterprise prices for a doc repo? Editor V2 auto-maps Technical File changes with visual checkpoints & approval triggers.