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
Recruiting compliance staff

  • Hard to find
  • Expensive & fix costs
  • Needs proactive attention to proceed towards CE certification.

Hiring and managing Notified Body

  • Hard to find in time
  • Becomes harder with MDR
  • Constantly communicating, planning.

Obtaining and maintaining QMS ISO 13485

  • Fully dedicated quality responsibles
  • Underestimated fix costs (staff, (re-)certifications, audits, tools etc.).
  • Improve the QMS and re-certify regularly.
  • Keep up the processes meeting changing standards.

CE marking

  • Needs specific experience for documentation and process
  • Audits of critical suppliers

Managing post-market maintenance

  • High introduction efforts (tools, infrastructure etc.)
  • Periodic updates of documentation compliance
  • Implementation of divers ongoing processes

Your Benefits

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 mark.
  • You operate on our ISO 13485 QMS.
  • You get the tools and processes.

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

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.