Want to Work with Decomplix?


Outsource Your CE Certification

Medical Device
Get Market Access
for Your Product
Obtains & Maintains
Your CE Mark

Focus on your Business.
Not on Regulatory Compliance.

discover our offer

CE Marking is a Journey. What would it take to certify on your own?

ISO 13485 Certification

  • Finding expensive compliance staff.
  • Time-consuming hiring a Notified Body.
  • High involvement through establishing QMS.

CE Marking

  • New demanding project on top of daily business.
  • Needs compliance and regulatory experience.
  • Running delicate supplier audits.

Post-Market Compliance

  • Different markets increase the complexity.
  • Near-time Incident Reporting and FSCA.
  • Meet changing laws and standards.

Your Benefits with Decomplix

Create Caluculability

  • Calculable certification costs.
  • Shorter time-to-market.
  • Pay as you grow and flat fees.

Minimize Risks

  • Access our compliance staff.
  • We invest in your CE marking.
  • Connect with our Notified Body.

Transfer Responsibility &
Hands-On Guidance

  • We are responsible for the CE.
  • You get the tools & processes.
  • You operate on our ISO 13485 QMS.

Your Questions, Our Answers

Decomplix offers you CE marking and hassle-free maintenance for your product in a much shorter 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
  • Pre-market fee
  • Shared revenue
  • Equity shares

The product is certified under the Decomplix name. Developers retain intellectual property and product brand. Decomplix must be named on the product label, but without a logo.

Certification by Notified Body, project management, guidance and training, perform phase reviews, review and release of technical documentation, write the technical documentation summary, audits of suppliers, legal affairs.

During the obtaining phase, you have to write the technical documentation because you know your product best. But don’t worry we’ll guide you. After entering the market, you have a reporting obligation & cooperation duty for resolution finding.

Re-certification of the product’s CE mark, secure conformity in target markets and report to customer, performing audits, handling of Notified Body relations, post-market surveillance (PMS), complaint and CAPA handling, incidence reporting and field safety corrective action (FSCA), update of reports, risk management, clinical evaluation and writing management reviews.

This partnership is a longterm collaboration which has a 3-year duration, from the first product placement on the market.

Yes, you can terminate the partnership at any time, e.g. for an exit.

Latest News on our Blog

14.02.2018 Claudia

Decomplix’ first CE!

QS Zürich issued a CE mark for EXVASIN and NephroPatch to Decomplix this week. With this, we reached an important milestone: The CE certification outsourcing with Decomplix works! Decomplix is now a legal manufacturer.

About the customer and the product: The Vostra-Med Ltd. from Zug is led by an experienced MedTech team. It develops and distributes sterile silicone patches, also known as «External puncture closure devices» for nephrology, cardiology and radiology. The elastic strips are used to close blood vessel punctures after medical treatment. It is used as a substitute the manual or mechanical compression of punctures by the patient or nursing staff. It allows, for example, dialysis patients, who are obliged be treated several times a week in a hospital/practice to go home much faster which improves their quality of life significantly.

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