Medical Device CE Mark Certification Consulting - Operon Strategist

Medical Device CE Mark Overview

CE Mark Medical Device  is a Certification mark for Health, Safety and Environment protection standards to sell medical products in EEA (European Economic Area), CE mark is recognized worldwide. CE Mark is a declaration by manufacturers that, the products they are sell in EEA are meeting the requirements of  EC Directives. In order to market products in the European market, the products must have a CE mark which declares that a product meets all relevant European Medical Device Directives.

The benefits of CE certification is that it is a legal requirement to trade your device in the European market.

The CE Mark is a conformity mark which all medical devices must have before they can be marketed. It is seen as a declaration by the manufacturer that the product meets all the provisions of the relevant directive. Devices are classified based on their contact.

What is CE Mark Technical File or Design Dossier Compilation and Review?

Compiling your technical file or design dossier is a critical step in Europe’s CE certification process and a requirement for compliance with the Medical Devices Directive 93/42/EEC. In Vitro Diagnostic Medical Devices Directive 98/79/EC, or Active Implantable Medical Devices Directive 90/385/EEC.

CE Certification Process

We help you understand and meet the regulation to ensure your product completes the CE Marking process efficiently and successfully. And answer the questions. How to get ce mark for medical device ? and Medical Device CE Mark certification process.

Before the CE Mark may be affixed to a medical device and legally sold within the European Union, the manufacturer or exporter must complete the following:

• Prepare Technical Documentation (Technical File) to show the product’s compliance with applicable essential requirements and conformity assessment procedures of the applicable device directive
• Register their device with the appropriate Competent Authorities
• Receive a device-specific CE Certificate from a Notified Body (Class I devices do not require a certificate from a Notified Body)

Operon Strategist is a medical device consulting company. We are supports clients in meeting “European submission” standards that declares the product offered is in compliance with the Essential Requirements of relevant European safety, health and Environmental protecting regulation.

We are leading Medical Device CE Certification Consultant for medical device disposable implant manufacturers, medical disposable syringe manufacturers, surgical instrument manufacturers, orthopedic implant & instruments manufacturers, laboratory equipment manufacturers, sterilization equipment and accessories manufacturers, medical imaging systems manufacturers.

Read More - CE Mark Medical Device 

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1. Orthopedic Implants Manufacturing
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3.Blood Collection Tubes Manufacturing
4. How to start the Manufacturing of Disposable Syringes?

Contact details –

Phone  no -  93702 83428

Mail id – enquiry@operonstrategist.com

If  You Want Medical Devices Services Consultation For Following.

1. Medical Device Consulting 
2. cdsco registration 
3. FDA 510k Clearance 
4. ce mark medical device 
5. CDSCO Manufacturing License 
6. CDSCO import license 
7. TURNKEY PROJECT CONSULTANT 
8. medical device manufacturing 
9. iso 15378 certification 
10. 21 cfr part 210 and 211 
11. ISO 13485 Medical Device Consultant 
12. Primary Packaging Turnkey Project Consultant 
13. Clean Room Design Consultant 
14. manufacturing site conceptualization 
15. Market Analysis and feasibility for Medical Devices 
16. manufacturing plant layout design 
17. medical device design and development 
18. DMF file submission guideline 
19. 21 cfr part 820 
20. qms certification services 
21. design control requirements 
22. medical device process validation 
23. combination product 
24. continuous improvement program 
25. Medical Device Compliance & Regulatory Services 
26. Cdsco India authorized agent for medical device