Medtech World · Malta

From strategy to
market authorisation.

Quality and regulatory consultancy for hardware, software and AI-enabled medical devices, from engineers who speak regulatory.

US FDAEU MDRUK MDR
What we do
01

Quality assurance

A Quality Management System (QMS) that fits your stage, and experienced people to run it.

  • Quality Management System
  • eQMS selection and set-up
  • Internal and supplier audits
  • CAPA and change control
  • Post-market surveillance
  • Support with Notified Body audits
  • Fractional QA lead
02

Regulatory affairs

A clear route to market in the UK, EU and US, and submissions that hold up to review.

  • Regulatory strategy
  • FDA submissions
  • EU MDR technical file
  • UK MDR technical file
  • UK and EU registrations
  • Notified Body and FDA liaison
03

Technical evidence

The documentation regulators expect, written by engineers who have built and tested medical devices.

  • Software
  • AI
  • Risk management
  • Cybersecurity
  • Usability
  • Clinical
04

Testing support

Planning, preparation and lab liaison for testing carried out by accredited test labs. We do not run the tests ourselves.

  • Electrical safety
  • EMC
  • Wireless and radio
  • Cybersecurity
  • Pre-compliance reviews
  • Test report review

Let's plan your route to market.

Tell us about your device and target markets. We'll suggest where to start and what it will take.

Let's talk