Welcome to our website which provides information for manufacturers of medical devices on their responsibilities when placing a product on the European market.
If you want to obtain CE marking and become a European producer feel free to contact us. We are here to help you gain market access in Europe with CE marking.
What we do ?
CE Support is an advisory team in the medical sector. We provide manufacturers of medical devices with an open and honest assistance. We will work in partnership with you, helping you to understand and comply to the essential requirements, and enabling you to confidently and legally affix CE marking to your products.
We deal with classification of a medical device, preparation of necessary documentation, provide support during and after implementation of ISO and help to maintain it. CE Support assist you to register your product at the Office for Registration of Medical Devices and any other processes enabling you to market and sell your devices in Europe.
Our ambition is to help manufacturers of medical devices to improve their competitiveness on the market by introducing new products, searching new business areas and importing devices from outside European Union. We successfully perform corrective actions needed by the Office for Registration of Medical Devices after the inspection.
CE Support also provides consulting services regarding RoHS and WEEE policies compliance.
We believe in creating proper systems and procedures that are beneficial for the business for the long run. This means that our cooperation will not end along with the certification process, documentation completion or the registration of the device. Once the basic operations are finalized we are still on call to support our business partners answer any question regarding certification, ISO, annual audits or solve any other problems.
If you what be European Producer we can set up a new company in Europe for you – which you will be owner, then we make ISO 13485 and in the end we make CE certificate for your products. Your products will be Made in Europe. There will not be any kind of production in Europe. All production will be in China. In Europe we make only documents. You don`t need to open expensive offices or employ any workers. During all stages we give your company full support.
Who we are
Team CE Support is a group of young people from Europe. You will benefit from our expert knowledge, experience, independence and resources.
All of us are specialist from various fields. In our team we have doctors, physiotherapist, lawyers, technical specialist – engineers, electronics, ISO specialists.
Medical Directive MDD 93/42/EWG defines ‘medical device’ as any instrument, apparatus, appliance, software, material o other article to be used specifically for diagnostic or therapeutic purposes, intended to be used for human beings for the purpose of:
- Diagnosis, prevention, monitoring, treatment or alleviation of disease, or
- Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, or
- Investigation, replacement or modification of the anatomy or of a physiological process, or
- Control of conception
Medical Directive 93/42/EWG defines also products that this Directive shall not apply to:
- Medicinal products,
- Cosmetic products,
- Human blood, blood products,
- Transplants or tissues or cells of human and animal origin
Conformity assessment system for medical directive
Directive introduces 6 conformity assessment systems:
- Full quality assurances system;
- EC-type examination;
- EC verification;
- production quality assurances system;
- product quality assurance system;
- declaration of conformity EC.
They are closely connected with the category of the product. It is essential to classify the product to choose the proper conformity assessment procedure.
European Commission divides medical devices into 4 Classes in accordance with 18 rules. For each device only one rule can be adapted. These 4 Classes are:
- Class I devices
- Class IIa devices
- Class IIb devices
- Class III devices
There are various conformity assessment procedures available for each Class and the manufacturer can decide which procedure to use.
PN-EN ISO 13485:2012 Quality management system was written to support medical device manufacturers.
ISO 13485 is a Management Systems Standard specifically developed for the manufacture of Medical Devices. Implementation of a Quality Management System usually entails assessing compliance with European Directive statutory requirements. PN-EN ISO 13485:2012 has been based on ISO 9001:2008 but is extended by requirements typical of medical sector. Its primary objective is to facilitate harmonized medical device regulatory requirements.
Benefits of being certified to PN-EN ISO 13485:2012
ISO 13485 is the international standard that defines quality management system requirements for organizations that design and develop, manufacture, install and service medical devices and design, develop, and provide related services, including manufacturers of materials or component parts that are used in medical devices.
Here are some benefits of implementing PN-EN ISO 13485:2012:
- Improved performance;
- Improved competitiveness;
- Client satisfaction;
- Recognized globally as the best quality practices within the medical device industry;
- Expanded market access;
- Reduction of costs as a result of minimizing product failures
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