Independent quality and regulatory support for medical device manufacturers. Clear day rates, remote or on-site, with half days available.
Day rates
| Service | Scope | Rate |
|---|---|---|
| QMS Internal & Supplier Auditing | ISO 13485:2016, ISO 9001:2015, audit report and CAPA follow-up | £600/day |
| Certification Readiness | Gap analysis, Stage 1 and Stage 2 preparation, mock audits | £600/day |
| MDSAP Preparation | 1–2 jurisdictions £600, 3+ jurisdictions £650 (US, CA, BR, AU, JP) | £600–650/day |
| Regulatory & Technical Documentation | UK MDR, EU MDR/IVDR technical files, ISO 14971 risk files, FDA; priced by complexity | £600–700/day |
| Ad Hoc Advice | Questions, document reviews, regulator or notified body queries (1 hour minimum) | £85/hr |
Introductory rates are available for new clients on request.
Packages
ISO 13485 Gap Assessment
Two-day assessment of your QMS against ISO 13485, with a prioritised action plan and debrief.
£1,200 fixed price
Fractional Quality Lead
Regular QA/RA support covering management review, CAPA, PMS and audit cover. Three-month minimum.
£2,400/month (4 days)
Regulatory Training
Online modular courses: ISO 13485, ISO 14971, EU MDR, FDA and AI in regulatory affairs. In-house on request.
£495 per delegate
Rates exclude VAT where applicable. Travel and accommodation for on-site work are charged at cost. Fixed-price quotes are available for defined scopes. Invoiced monthly in arrears on 30-day terms.