We provide CE marking for medical devices and apps in 1⁄2 the time-to-market

Market Access & Risk Hedging
Medical Device Providers
Certifies Medical Devices as a Legal Manufacturer

Are you a medical device start-up, new entrant or non-European manufacturer?

We understand you!

CE Marking

CE marking of a medical device is mandatory within the European Union to gain market access. For new entrants, obtaining CE marking in unknown territory can be a time consuming process.

ISO 13485

Obtaining ISO 13485 takes considerable effort and can be expensive. In order to obtain a CE marking, you will need a quality management system that meets this standard.

Specialised Know-how

You need highly specialised expertise to implement a product and quality management system that conforms to the correct standards. Finding and hiring this expertise can be frustrating, time consuming and expensive.

Your Questions, Our Answers

Decomplix offers you CE marking and hassle-free maintenance for your product in half the time.

You get to concentrate on your core business of innovation, design, development and marketing.

You choose from our four pricing options that suits your product and company best.

  • Monthly subscription fee
  • Initial service fee
  • Shared revenue
  • Equity shares

Who benefits from Decomplix?

Medical device companies

  • CE marking in half the time
  • Hedged risk
  • Partial payment with shares
  • Fewer concerns about quality management

Investors in medical device companies

  • Minimised risk
  • Calculable time
  • Secured quality know-how
  • Enforced ROI

Non-European manufacturers

  • No European Authorised Representative (EAR) needed
  • CE marking in half the time
  • Hedged risk
  • Fewer concerns about quality management

Health Care & MedTech Industry

  • Acceleration of innovation
  • New approach for market access
  • Early stage support
  • Start-up screening

Want to Work with Decomplix?

Do you know someone looking for a challenging experience? Are you stimulated by the idea of building up a company that occupies a first-mover advantage on the market? Do you thrive on variety?

Let’s talk!
Quality Manager mHealth & Medical Devices