Want to Work with Decomplix?

JOBS

Outsource Your CE Certification

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

Focus on your Business. Not on Regulatory Compliance.

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?

Create Caluculability

  • Easy calculation of certification cost
  • More calculabe & shorter time-to-market.
  • Pay-as-you-grow and flat fees.

Transfer Responsibility &
Hands-On Guidance

  • We are responsible for your CE mark.
  • You run on our ISO 13485.
  • We have the tools & processes in place.

Minimize Risks

  • You get our compliance staff.
  • We invest in your CE marking.
  • Don’t worry about hiring a Notified Body.

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

The product is certified under 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 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 product’s CE mark, secure conformity in target markets and report to customer, performing audits, handling of Notified Body relations, Post-Market Surveillance (PMS), complaints- & CAPA handling, Incidence Reporting & Field Safety Corrective Action (FSCA), update of reports (Risk Management, Clinical Evaluation, PMS), writing of 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

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.