Project Description
My Class I medical device is already on the UK market, so the initial MHRA registration is complete. What I need now is targeted, post-approval support to keep every part of the technical documentation fully aligned with the most current MHRA requirements.
The immediate priority is to review and update all post-market files that have changed since the original submission—especially the Technical File, PMS reports and any vigilance-related records—so that an inspector can see a clean, gap-free audit trail at a moment’s notice. You’ll be working only on documentation updates; no new clinical studies or lab testing are required.
I’m looking for someone who has demonstrable experience with UK MDR 2002 (as amended), understands the nuances of MHRA guidance notes and can turn around well-structured, citation-ready documents quickly. Familiarity with ISO 13485 and the current standard PMS and PSUR templates will help you slot straight in.
Deliverables (all in editable Word or Excel formats, plus a signed change log):
• Updated Technical File sections affected by design, labeling or supplier changes
• Revised PMS plan and latest PMS report, incorporating new complaint data
• Clean copy of the vigilance log with any reportable events flagged and cross-referenced
• Consolidated change-control register showing every document revision
I’ll provide the existing submission pack and raw post-market data as soon as we start, and I can answer questions daily to keep momentum high.