Want to Work with Decomplix?

JOBS

Outsourced CE Certification

Market Access
& Risk Assumption
Medical Device
Developers
Certifies Medical Devices
& Maintains Certifications

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

discover our offer
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 quality management system that conforms to the standards. Finding and hiring can be frustrating, time-consuming and expensive.

Who benefits from Decomplix?

Medical Device Developers

  • Calculable cost & time
  • Transferred risk
  • Faster CE marking
  • Safe certification maintenance

Medical Device Investors

  • Minimised risk
  • Calculable cost & time
  • Secured regulatory know-how
  • Enforced ROI

Non-European Manufacturers

  • Calculable cost & time
  • Well-connected partner
  • Secured regulatory know-how
  • No Representative (EAR) needed

Health Care & MedTech Industry

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

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

Latest News on our Blog

01.06.2017 @decomplix

As a digital healthcare leader, Denmark is troubled by tech disruptors. #medicalapps #wearables #data https://t.co/ocbseOtMwP

19.05.2017 @decomplix

Very proud of our buddys next door. Congrats! #medicaldevice #startup #SaMD https://t.co/HUZLSbv6MJ

19.05.2017 Claudia

Joint Venture augmented

Decomplix AG was founded in June 2016 as a joint venture between established companies and professionals. The mission is to accelerate innovation by shortening the time-to-market and simplifying market access for medical devices. The founders are Hansjörg Riedwyl & Partner of the Medtech service provider ISS AG, the innovation agency Creaholic SA, the law firm Beutler Künzi Stutz AG and Beni Hirt from the app business. The multidisciplinary team has been augmented with two partners: netrics AG

As a leading swiss managed service provider and cloud pioneer, netrics AG provides IT services from its own data centers in Switzerland in combination with public cloud offers. Decomplix can connect its client’s medical apps and wearables with cloud services from secure data centers from the ISO 27001 certified netrics AG.