CE Marking Consultants

CE Marking Consultants (Medical Device)

Medical Device fraternity is now dreadfully aware of the hardships in obtaining Invitro Diagnostic and Medical Device CE Marking. The new Medical Device Regulation (MDR) and In-vitro Diagnostic Regulation (IVDR) demand greater and more detailed documentary evidence to demonstrate SAFETY, EFFICIENCY and PERFORMANCE of your device as intended by the manufacturer. We highlight some of the key factors and advantages which we aspire manufactures should know before appointing CE Marking Consultants.

We CE Marking Consultants help new Medical Device manufacturers to introduce a new device into the EU market or need assistance in transitioning an existing medical device Technical File to MDR. Check out below how we help.

GAP analysis of your existing Technical File.

Send us your current technical documentation (TCF) to find what is missing and what has to be added. Our team of medical device consultants will go in depth of your device design, risk analysis biological safety, electrical safety, clinical evaluation, testing reports, post market surveillance, labeling, and much more areas and provide you with a clear picture of gaps and what measures to be done.

MDD to MDR Transitioning of existing medical devices Technical File(s).

New EU Medical Device Regulation (MDR) imposed new requirements on manufacturers to demonstrate the safety, efficacy and performance of their devices through technical documentation. We observed large number of manufacturers currently have CE Certificate under MDD do not have adequate supporting technical documentation to meet the new Medical Device Regulation (MDR). We medical device consultants can thoroughly examine your existing Technical File and upgrade with high quality contents especially in Clinical Evaluation Report, Post Market Surveillance , Post Market Clinical Follow Up, Risk Files and Public Information Panels.

Rooted Medical Device CE Mark Consultants, started in the year 1999. I 3 CONSULTING has well established partner networks and offices in the EU, INDIA, USA and UAE. Manufacturers, our existing customers do not consider us as consultants but as outsourcing partners for Medical Device Regulatory compliance all through the year.

Steps followed by CE Marking Consultants

  • Understand the device and identify applicable regulatory requirements and device risk class.
  • Identify equivalent devices with the help of client team.
  • Identify Route of CE Marking.
  • Biological & Safety assessment and send device for external laboratory testing
  • Start drafting the Technical File.
  • Planning for Post Market Surveillance
  • Planning for Post Market Clinical Follow up
  • Planning for Clinical evaluation
  • Review and updating of Risk Management file and usability records
  • Support in Quality Management System implementation as per ISO 13485:2016.
  • Review, suggestions on Verification & Validation Documents and Reports
  • Label review as per ISO 15223-1.
  • IEC 62304 Implementation support (Software CE Marking)
  • Support in Identifying the Notified Body.
  • Final Review and submission of Technical File to Notified Body
  • Answering to Notified Body Review comments
  • Support during certification and annual surveillance audit.

Advantages of OUTSOURCING Technical Documentation and Maintenence to I 3 CONSULTING

  1. We have Worldwide network and team of CE Marking Consultants, Lead Auditors & Medical Writers.
  2. Largest customer base in Asia for Medical Device CE Marking & USFDA 510k.
  3. We handle all type of New or patented Device!! Handles any risk class!
  4. One-Stop Solution for Medical Device Testing.
  5. One-Stop Solution for Medical Device European Authorized Representative
  6. One-Stop Solution for Medical Device European Free Sale Certificate.
  7. Retrospective Post Market Clnical Follow Up study (majority of the commonly used Medical Devices)
  8. In-House Clinical Evaluators (majority of the commonly used Medical Devices)
  9. We support for Drug Device Combination and Active Implantable Devices.
  10. Cloud documentation. Clients can access and monitor the progress 24 x 7 from any where.
  11. No worry of employee leaving the organization. Your files are in safe hand throughout the year.
  12. Onsite & Offsite Medical Device CE Mark Consulting service. World most economic service provider!!

We are CE Marking Consultants providing services across the Globe from the year 1999. Our clients are from various countries and cities. 1. USA (New York, Los Angeles, Chicago, Houston, San Antonio, San Diego, Dallas, Boston, New Jersey and Miami), 2. UK (London, Birmingham, Manchester, Liverpool, Newcastle, Sheffield) 3. Germany (Berlin, Bonn, Hamburg, Munich, Cologne, Düsseldorf, Mönchengladbach, Hannover, Augsburg, Wuppertal) 4. India (New Delhi, Bangalore, Mumbai, Chennai, Pune, Ahmedabad, Kochi, Hydrabad, Kolkatta, Goa, Coimbatore) 5. UAE 6. France 7. Netherland 8. Australia 9. South Africa 10. Spain 11. Norway 12. Mexico 13. Canada 14. Malaysia 15. Singapore 16. South Korea 17. Egypt

Client Testimonials...

Surgick LLC; Commended by Sam Issac on . Good Team Work!!!. Ontime submission of Technical File to Notified Body. Quality File. I recommend I 3 CONSULTING to any others in-need. Rating: 4.9

INDIA – Bangalore
+ 91 994 591 2081
Phone / WhatsApp

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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