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deviCE Sistemas

Experts in CE Marking for Medical Devices and Machinery
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Who are deviCE sistemas?

deviCE sistemas is a consultancy firm and we assist manufacturers in obtaining the CE Marking for their product(s). We provide professional yet close and personalized support, adapting to the needs of our client.We are continuously training and accrediting in the various fields related to CE Marking legislation.
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Teamwork meeting, tablet and business people in office workplace. Collaboration, technology and workers, men or employees with touchscreen planning sales, research or financial strategy in company.
Teamwork meeting, tablet and business people in office workplace. Collaboration, technology and workers, men or employees with touchscreen planning sales, research or financial strategy in company.

Who are deviCE sistemas?

deviCE sistemas is a consultancy firm and we assist manufacturers in obtaining the CE Marking for their product(s). We provide professional yet close and personalized support, adapting to the needs of our client.We are continuously training and accrediting in the various fields related to CE Marking legislation.
Read about us

Services

CE Marking for medical devices (MDR) and in vitro medical devices (IVDR).

Administrative procedures (AEMPS, EUDAMED)

CE Marking for machines, regulatory compliance.

Implementation and Audits ISO 13485

Technical Manager

CE Marking Software for medical and in vitro products.

Regulatory Compliance Officer

All services

deviCE Sistemas offers personalized consulting and advisory services on everything related to CE Marking legislation.

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At deviCE Sistemas, we help your company obtain the CE Marking for your product.

What is CE Marking?

The CE Marking is the mark obtained through the process by which a product manufacturer indicates that it complies with all applicable requirements established in European community harmonization legislation. The CE Marking guarantees the safety and quality of a product so it can be marketed in the European Union and serves as a passport for products, ensuring their free circulation in the European Economic Area (EEA).

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Scientist working in laboratory with microscope
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What is CE Marking?

The CE Marking is the mark obtained through the process by which a product manufacturer indicates that it complies with all applicable requirements established in European community harmonization legislation. The CE Marking guarantees the safety and quality of a product so it can be marketed in the European Union and serves as a passport for products, ensuring their free circulation in the European Economic Area (EEA).

At deviCE Sistemas, we help your company obtain the CE Marking for your product.

Why is CE Marking important?

Besides being a legal requirement, to be marketed, they must meet the technical criteria set out in the applicable European Union harmonization legislation, including the placement of the logo on the product or accompanying documentation, regardless of the product’s place of manufacture.We are experiencing a significant change in medical device regulation. This change entails numerous modifications in the practices of companies related to the medical device lifecycle and, in many cases, an increase in their obligations.
Read about CE Marking
Scientist working on a pharmaceutical industry machine
Scientist working on a pharmaceutical industry machine

Why is CE Marking important?

Besides being a legal requirement, to be marketed, they must meet the technical criteria set out in the applicable European Union harmonization legislation, including the placement of the logo on the product or accompanying documentation, regardless of the product’s place of manufacture.We are experiencing a significant change in medical device regulation. This change entails numerous modifications in the practices of companies related to the medical device lifecycle and, in many cases, an increase in their obligations.
Read about CE Marking

At deviCE Sistemas, we help your company obtain the CE Marking for your product.

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