CE Marking Consultants for Medical Device

As part of the CE Marking process, Medical Device Technical File will be reviewed by Notified Body for supporting evidence in compliance to essential requirements. The help of an experienced Medical Device CE Marking consultants like I 3 CONSULTING will make the CE Certification path easy by preparing and submitting the Technical File to Notified Body until client gets CE Certificate.

I 3 CONSULTING team of CE Mark Consultants, highly qualified and experienced in various type and class of medical device only can successfully guide you through the entire process of Medical Device CE Marking.

Below detailed the major reasons why an experienced CE Marking Consultants is recommended for Medical Device CE Certification.

  • Medical Device CE Marking Consultants must understand your device and its applicable regulatory requirments faster than anyone.
  • CE Mark Consultants must always have prior experience in handling similar Medical Devices.
  • Guidance and support in preparing Technical File /Design Dossier.
  • Medical Device CE Marking Consultants includes experienced medical writers for developing clinical evaluation report as per MEDDEV 2.7/1 Rev. 4.
  • Support in conducting the Risk Analysis and Usablity Records.
  • Quality Management System implementation as per ISO 13485:2016.
  • Identify the applicable Harmonized standards.
  • CE Marking Consultants have the necessary knowledge and expertice to review and comment external test report.
  • Review of Verification & Validation documents.
  • Medical Device CE Marking Label Review as per ISO 15223-1.
  • Identifying the class and applicable rule of Medical Device.
  • CE Mark Consultants identify the main route of CE Marking.
  • CE Marking Consultant will prepare the Declaration of Conformity.
  • Identifying the Notified Body.
  • Support during Certification and annual Surveillance Audit.
  • Others like
    1. Proper guidance on Implantable, Active Implantable, Animal Origin & Drug Device combination products.
    2. Technical support for IVD Device.
    3. Electro-Mechanical and ROHS, PED combination Devices  as per 2007/47/EC.
    4. Software CE Marking.

Our CE Marking Consultants capable of handling Drug-Device combination products!!!

Advantages of appointing CE Marking Consultants from I 3 CONSULTING

  1. Worldwide network and team of Medical Device CE Marking Lead Auditors, Medical Writers and Consultants.
  2. Largest customer base  in Asia for Medical Product CE Mark & FDA 510k.
  3. We handles all type of New or patented Device!! Handles any risk class!!
  4. One Stop Solution for Medical Device Compliance covering Technical File, Testing, Notified Body & EAR Service.
  5. Onsite & Offsite (online) consultancy with very normal fee.

Any additional clarification kindly contact us.

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INDIA – Bangalore
+ 91 994 591 2081
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USA – Chicago
+1 630 696 1293
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GERMANY – Bremen
+49 2161 990 8831
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mail enquiry@i3cglobal.com
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