One Stop Solution For Medical Device CE Marking
CE Marking covering reusable medical devices, equipment, disposables, implants, drug-device combination products, and home healthcare devices across all classes spanning a diverse range of indications. We have the experience and expertise to prepare technical documentation with any Notified Body of your choice.
Testing is essential to demonstrate General Safety and Performance of the device
All Non European manufactures must appoint European Authorized Representative
Technical Documentation or Technical File is to demonstrate the safety and performance of medical devices
Technical Documentation & Support I Testing I Clinical Evaluation I EU Representative I Risk Analysis
CE (Communauté Européene) Marking of home and hospital patient healthcare devices needs CE Mark Logo is mandatory to enter the European Union (EU) large market of over 350 million wealthy consumers. Considering the advantages of CE Marking for medical devices all manufacturers are forced to apply CE Certification not only from Europe and also from other parts of the world. Large and corporate device manufacturers usually have sufficient staff in the regulatory affairs department.
In the case of small and medium-sized companies that do not have much technical expertise or full-time employees confused and uncertain of what is required to obtain CE Marking for Medical Devices including what documents and how much it will cost. For small and Medium-sized companies it is difficult to prepare technical files because they usually lack knowledge and previous experience for the sizable tasks involved as per MDR and IVDR documentation. Usually, this gesture and consultant role is vital.
Why Choose Us?
We are a Premium Regulatory Compliance Solutions Provider for Medical Device/IVDs
To excel and transcend the medical device manufacturers to their utmost level to the new and most awaited Europe's 2017/745 MDR and 2017/746 IVDR
The European Free Sale Certificate (FSC) or the Certificate of Free Sale (CFS) is the evidence
New MDR & IVDR regulations has made significant changes compared to previous (Directive) classification system
Standard dummy text ever to the since the 1500s, when an unknown the printer took a galley.
NB process EUDAMED is the European Database an IT system proposed by the European Commission
Unique Device Identification (UDI) system helps in device identification and facilitate the traceability of devices.
CE Marking of "Systems" or "Procedure Packs" or "Kits" detailed in MDR 2017/745 article 22
NB process detailing the requirement of the MDR relating to a device have been fulfilled
Usability refers to the user interface characteristic which establishes user learning and user satisfaction,
Medical Devices labelling is complex and needs appropriate information and knowledge how and what
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