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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 CE Marking

Medical Device CE Marking Services covering reusable medical devices, equipment, disposables, implants, drug-device combination, and home healthcare devices across all classes spanning a diverse range of indications.

 

We have the experiences and expertise preparing 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 I Technical 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.

Medical Device CE Marking 1

Discover how our services fit for you

Why Choose Us?

We are a Premium Regulatory Compliance Solutions Provider for Medical Devices/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

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 detailing the requirement of the MDR relating to a device have been fulfilled

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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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