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Medical Device CE Marking Services PREMIUM SERVICES We never let you in dark. We accompany you till Certification FOR MEDICAL DEVICE CE MARKING
Technical Consultants

One among the largest pool of talented teams in the world.

Document Control

ISO 27001:2013 Certified data security system. NDA with team members.

Annual Maintenance

Technical files updated throughout the year by our team.

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

MDQMS Implementation is mandatory of medium and high risk devices for CE Marking

In Vitro Diagnostic Regulation (IVDR) is the new

Technical Documentation or Technical File is to demonstrate the safety and performance of medical devices

MDR article 61 and MEDDEV Rev 4, must be documented and CER

Technical Documentation & Support I Testing I Clinical Evaluation I EU Representative I Risk Analysis

Medical device manufacturers today are challenged by the regulatory authorities.

You need support to stay and regain CE Certificate validity. That’s where we come in.

Discover how our services fit for you

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.

 

>>>  EU Medical Device Regulatory Process as per MDR 2017 >>>

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.

MDR & IVDR Up-to-date information of notification status of Notified Bodies can be found

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

Manufacturers legally obligated to report serious incidents and Field Safety Corrective Action as per MDR Section 2, article 87.

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

EU MDR replaces the essential requirements (ER) by general safety and performance requirements

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Do you have questions about Medical Device CE Marking? Contact us today, we’re here to help.