25.06.2020
Business
We take care of your product’s CE certification,
so jump aboard.
You can shorten the process, skip steps and stop at any time. We tailor our team to your individual needs. If you think we could support you in any way, let’s talk!
Choose CE marking services that match your needs
* Decomplix helps start-ups or companies in an expansion phase by taking over parts of the CE certification costs in exchange of a participation in product sales revenues. You can choose between pricing options at any stage depending on the contract agreement.
YOU WANT TO
Request a quoteWE OFFER
… an expert assessment of your situation in a workshop.
- Strategic options and immediate actions to obtain the medical CE mark in the EU
- Roadmap that defines all steps and responsibilities
- Case-related regulatory aspects
- Essentials required for your technical documentation
- Practical advice on your needs about the European CE marking process
YOUR BENEFITS
You know precisely what has to be done.
- Strategic decision support
- Cost estimate
- Flat workshop fee
WE OFFER
… the best way for your CE certification.
- Profound knowledge from our pool of proven experts
- Compliance staff recruiting
- Finding a Notified Body
- Setting-up your ISO 13485 Quality Management System
- Ensuring your technical documentation’s compliance with General Safety and Performance Requirements (GSPR)
- Performing audits and supplier qualifications/ monitoring
- Guidance during the conformity assessment & certification
YOUR BENEFITS
You take the fast-track to the CE mark.
- No unnecessary rounds
- Focus on sales for your success
- Full cost control with subscription or hourly fee
WE OFFER
… all actions necessary for your ongoing compliance.
- Maintenance of your QMS ISO 13485 & technical documentation to ensure continuous compliance
- Preparation for the entry into additional markets
- Post-market surveillance of your product including required report updates (e.g. PMSR, CER, PSUR, RMR)
- Complaint- and CAPA handling, incident reporting and product recalls
- Communication and interaction with the Notified Body
YOUR BENEFITS
You can focus on sales, we on compliance.
- Lean CE maintenance
- Reduced product risk
- Full cost control with subscription or hourly fees
WE OFFER
… to assume your product’s risk by acting as its legal manufacturer.
- Maintenance of your product’s technical documentation so it remains compliant
- Usage of our compliant and managed ISO 13485 QMS so you can skip steps and save time
- Management of all interactions with the Notified Body
- Provision of a liability insurance in case of complaints, incidents or recalls
YOUR BENEFITS
You can minimize your product risks.
- Protect your company value in case of product incidents
- Full cost control with subscription or hourly fee
- Pay as you grow and risk-based pricing
WE OFFER
… a smooth transfer of the CE certificate.
- Certification of the product under your name
- Recruitment of compliance staff and the management of compliance know-how
- Set-up and certification of your compliant ISO 13485 QMS
- Mentoring the transition to your Notified Body
YOUR BENEFITS
You can reallocate your resources.
- Decomplix empowers your compliance insourcing
- Realize your exit plans at any time
- Flat or hourly fees
Choose CE marking services that match your needs
* Decomplix helps start-ups or companies in an expansion phase by taking over parts of the CE certification costs in exchange of a participation in product sales revenues. You can choose between pricing options at any stage depending on the contract agreement.
WE OFFER
… an expert assessment of your situation in a workshop.
- Strategic options and immediate actions to obtain the medical CE mark in the EU
- Roadmap that defines all steps and responsibilities
- Case-related regulatory aspects
- Essentials required for your technical documentation
- Practical advice on your needs about the European CE marking process
YOUR BENEFITS
You know precisely what has to be done.
- Strategic decision support
- Cost estimate
- Flat workshop fee
WE OFFER
… the best way for your CE certification.
- Profound knowledge from our pool of proven experts
- Compliance staff recruiting
- Finding a Notified Body
- Setting-up your ISO 13485 Quality Management System
- Ensuring your technical documentation’s compliance with General Safety and Performance Requirements (GSPR)
- Performing audits and supplier qualifications/ monitoring
- Guidance during the conformity assessment & certification
YOUR BENEFITS
You take the fast-track to the CE mark.
- No unnecessary rounds
- Focus on sales for your success
- Full cost control with subscription or hourly fee
WE OFFER
… all actions necessary for your ongoing compliance.
- Maintenance of your QMS ISO 13485 & technical documentation to ensure continuous compliance
- Preparation for the entry into additional markets
- Post-market surveillance of your product including required report updates (e.g. PMSR, CER, PSUR, RMR)
- Complaint- and CAPA handling, incident reporting and product recalls
- Communication and interaction with the Notified Body
YOUR BENEFITS
You can focus on sales, we on compliance.
- Lean CE maintenance
- Reduced product risk
- Full cost control with subscription or hourly fees
WE OFFER
… to assume your product’s risk by acting as its legal manufacturer.
- Maintenance of your product’s technical documentation so it remains compliant
- Usage of our compliant and managed ISO 13485 QMS so you can skip steps and save time
- Management of all interactions with the Notified Body
- Provision of a liability insurance in case of complaints, incidents or recalls
YOUR BENEFITS
You can minimize your product risks.
- Protect your company value in case of product incidents
- Full cost control with subscription or hourly fee
- Pay as you grow and risk-based pricing
WE OFFER
… a smooth transfer of the CE certificate.
- Certification of the product under your name
- Recruitment of compliance staff and the management of compliance know-how
- Set-up and certification of your compliant ISO 13485 QMS
- Mentoring the transition to your Notified Body
YOUR BENEFITS
You can reallocate your resources.
- Decomplix empowers your compliance insourcing
- Realize your exit plans at any time
- Flat or hourly fees
From our blog
16.06.2020
Knowledge
Certification of a Quality Management System according to ISO 13485
11.05.2020
Knowledge
