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 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 Calculability

  • 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 CE 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

07.02.2019 @decomplix

Interesting update on the WHO’s nomenclature initiative on global harmonization of nomenclatures of medical devices… https://t.co/dYuPFSw52j

04.02.2019 @decomplix

New legislation on the distribution of medical devices published by the Belgian Minister of Health #MedicalDevices… https://t.co/hSExmaAffc

28.01.2019 @decomplix

RT @CovingtonLLP: Are #wearablemedical devices requiring a CE-mark in the #EU? @InsideTechMedia examines what “wearables” are, and when the…