Sunday, 17 October 2021
Thursday, 14 October 2021
Why Do You Need CE Marking Certification for Medical devices?
Are you Looking for a CE Certification of Medical device?
If yes then! You are at the right place, We have a Testing and Certification Body for Medical Equipment, We will provide you CE Certificate and Testing Service for Your Medical Equipment as per the Applicable directive: Directive (93/42/EEC)
If You Have Any Requirement For CE Certification
Please feel free to contact us
Mr. Puneet Sharma
+91-8196980555 +91-7986633030
Contact on Whatsapp https://wa.link/6lbssb
CE marking Certification in the medical device manufacturer's claim that a product meets the General Safety and Performance Requirements GSPR of all relevant European Medical Device Regulations and is a legal requirement to place a device on the market in the EU European Union.
The short answer is, you get to sell in more countries globally thereby increasing your footprint exponentially and also it helps in building credibility within the doctor’s community in India. Every country follows its own regulatory system, for eg: USFDA is for selling in the US. CE Mark Certification is mandatory to sell medical devices within any of the 32 European Union countries. It also validates that your device complies with all regulations put forward by European Union, which is accepted by many other countries too. However, the CE mark Certification is accepted by many countries and hence investment can be justified easily.
How To Get CE Certification For Medical device?
Here Are the 7 Steps for CE Certificate for Medical Devices:
Step 1: Classification
Step 2: Identification
Step 3: Technical Documentation
Step 4: Appointing a European Authorized Representative (E.A.R.)
Step 5: Certification
Step 6: Affixing the CE Marking
Step 7: National Provisions
Our Service Include:
- Technical Guidance
- Documentation Guidance
- On-site safety testing from NABL, BIS lab against EN60204-1,
- Pre-audit and CE certification from a notified body.
If you are interested to Get CE Certified your Medical Devices, Please Send us the following information to quote you:
- Name of product
- Product photograph
- Intended use of the product
- Technical specification of the product.
We are Providing Certification, Testing, and Inspections service all over India, Mumbai, Kolkata, Delhi, Chennai, Bangalore, Hyderabad, Pune, Ahmedabad, Surat, Visakhapatnam, Chandigarh, Ludhiana, Noida UP
If You Have Any Requirement For CE Certification?
Please feel free to contact us at +918196980555
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