Compliance Projects for Medical Device Manufacturers
Defined scope, a fixed-price quote, concrete deliverables. Six project areas that move your Class I, IIa or IIb device toward the EU market.
Services
The Six Projects
MDR Compliance Consulting
Gap analysis, classification support and a regulatory roadmap: know exactly where your device stands, and what is left before CE marking.
Technical Documentation
Technical files structured to Annexes II and III of MDR 2017/745, ready for Notified Body review.
ISO 13485 Implementation
A quality management system (QMS) built for your size: documented, operational, audit-ready.
Risk Management (ISO 14971)
A complete risk management file: hazard identification, control measures, residual-risk evaluation and benefit-risk rationale.
EUDAMED Registration
Actor registration, device registration and UDI (Unique Device Identification) data in EUDAMED — completed, verified and maintained.
Post-Market Surveillance
Post-Market Surveillance (PMS) plans, vigilance procedures and Periodic Safety Update Report (PSUR) preparation that keep you compliant after launch.
Method
How Every Project Works
Every project page follows the same structure: what is included, who it is for, what you receive, what is not included, and indicative timelines with the factors that influence them. No surprises — that is the point.
Pricing
How Pricing Works
Every project receives a fixed-price quote after the free initial assessment. The factors are your device’s complexity, the scope of work and the timelines — and the quote states them. No hourly billing, no hidden fees. Figures are provided on request — response within 24 hours on business days.
PRRC
Need Ongoing Coverage Instead?
These projects are one-off engagements with a defined end. If what you need is a permanent, continuously available regulatory role, that is the PRRC.
Ready to Scope Your Project?
Free initial consultation · Response within 24 hours · No obligation
Regulatory information last reviewed: 10 August 2026