New nexialist solution
![logo pyxis logo pyxis white](https://nexialist.fr/wp-content/uploads/2023/04/Logo-Pyxis_Logo-PYXIS-white.png)
The art of optimizing the process!
nexialist helps you streamline your CE mark process and build constructive communication between your QARA team and the NB.
![pyxis service de diagnostic dispositif médical](https://nexialist.fr/wp-content/uploads/2023/04/Pyxis-service-de-diagnostic-dispositif-medical.png)
![pyxis service de diagnostic dispositif médical](https://nexialist.fr/wp-content/uploads/2023/04/Pyxis-service-de-diagnostic-dispositif-medical.png)
PYXIS®
For whom?
PYXIS, is a new nexialist offer that aimed at:
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- MD manufacturers with CE marked products under Directive 93/42/EEC to be transferred under REG 2017 (EU)/745- not yet subject.
- MD manufacturers with new products to be certified directly under REG 2017 (EU)/745 – not yet submitted.
- MD manufacturers who have already submitted their technical documentation to the NB (to maintain the date set in advance). And who wish to anticipate the work of resolving deviations before having the NB’s first feedback on the initial evaluation. In order to avoid waiting sometimes up to 6 to 12 months for an answer.
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Why pyxis?
Ready for takeoff?
![icon chiffres plan de travail 1 01](https://nexialist.fr/wp-content/uploads/2023/04/Icon-chiffres_Plan-de-travail-1-01.png)
Real savings
Reduce the direct cost of certification by optimizing your evaluation process.
![icon chiffres plan de travail 1 02](https://nexialist.fr/wp-content/uploads/2023/04/Icon-chiffres_Plan-de-travail-1-02.png)
Your CE mark, our mission
Our multi-sectoral team at your disposal.
![icon chiffres plan de travail 1 03](https://nexialist.fr/wp-content/uploads/2023/04/Icon-chiffres_Plan-de-travail-1-03.png)
Your NB will love you
The « Pyxis by nexialist » label is a guarantee of trust, that reassures and facilitates communication with your NB.
![icon chiffres plan de travail 1 04](https://nexialist.fr/wp-content/uploads/2023/04/Icon-chiffres_Plan-de-travail-1-04.png)
Business anticipation
Tomorrow’s innovation is being built today: secure your business!
Some
figures
![pyxis avion](https://nexialist.fr/wp-content/uploads/2023/04/Pyxis-avion-scaled.jpg)
![chiffres rond 30](https://nexialist.fr/wp-content/uploads/2023/04/Chiffres-Rond-30.png)
OF VARIANCE AVOIDED
![chiffres rond 6 12mois](https://nexialist.fr/wp-content/uploads/2023/04/Chiffres-Rond-6-12mois.png)
MONTH OPTIMIZED TIME FOR THE CE MARK PROCESS
![chiffres rond 40k](https://nexialist.fr/wp-content/uploads/2023/04/Chiffres-Rond-40k.png)
AVERAGE DIRECT SAVINGS FROM YOUR NB PER TD
![chiffres rond45](https://nexialist.fr/wp-content/uploads/2023/04/Chiffres-Rond45.png)
OF THE TOTAL NEXIALIST ACTIVITY DEDICATED TO TD
Some figures
![pyxis avion](https://nexialist.fr/wp-content/uploads/2023/04/Pyxis-avion-scaled.jpg)
![chiffres rond 30](https://nexialist.fr/wp-content/uploads/2023/04/Chiffres-Rond-30.png)
OF VARIANCE AVOIDED
![chiffres rond 40k](https://nexialist.fr/wp-content/uploads/2023/04/Chiffres-Rond-40k.png)
AVERAGE DIRECT SAVINGS FROM YOUR NB PER TD
![chiffres rond 6 12mois](https://nexialist.fr/wp-content/uploads/2023/04/Chiffres-Rond-6-12mois.png)
MONTH OPTIMIZED TIME FOR THE CE MARK PROCESS
![chiffres rond45](https://nexialist.fr/wp-content/uploads/2023/04/Chiffres-Rond45.png)
OF THE TOTAL NEXIALIST ACTIVITY DEDICATED TO TD
![case study website plan de travail 1](https://nexialist.fr/wp-content/uploads/2023/07/Case-study-website_Plan-de-travail-1.png)
Case study
Isabelle
QARA Leader
The nexialist team in charge of our made valuable observations. Their constructive recommendations (strengths, weaknesses) led us and challenged us positively. Anything to remobilize our QARA team.
In the end, we acheived our objective: We provided the NB with relevant answers and obtained the CE mark in record time!