Thursday 14 October 2021

Why Do You Need CE Marking Certification for Medical devices?

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:

  1. Technical Guidance
  2. Documentation Guidance
  3. On-site safety testing from NABL, BIS lab against EN60204-1,
  4. 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:

  1. Name of product
  2. Product photograph
  3. Intended use of the product
  4. 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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Thursday 1 July 2021

9 Steps - How To Get CE Certification for Hydraulic Press?

CE Certification for Hydraulic Press Equipments

Are you Looking for a CE Certification of Hydraulic Press Equipments?

If yes then! You are at the right place, We have a Testing and Certification Body for Hydraulic Press Equipment, We will provide you CE Certificate and Testing Service for Your Hydraulic Press Equipment as per Applicable directive:- Machinery and Low Voltage Directive (LVD).


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 

Email: CE.Marking.Certification@Gmail.Com

https://ce-marking-india.blogspot.com/

https://cemarkingexperts.wordpress.com/


CE Marking is the most important Certification and  Passport for a product to sell in the European Market. If Hydraulic Press Equipment manufacturers have a CE certification mark, they can easily sell their Equipment in European Countries.


Here are the 9 Steps to Get CE certification for Hydraulic Press Equipment

  1. Step 1: Does the Safety of Machinery Directive apply to your product?
  2. Step 2: Check to see if your product is listed in Annex IV of the Safety of Machinery Directive.
  3. Step 3: Overview of CE marking requirements for the Safety of Machinery Directive.
  4. Step 4: Identify the European Standards for the Machinery Directive that apply to your product.
  5. Step 5: Meet the appropriate Essential Health and Safety requirements (EHSR’s) and establish a Quality Control System.
  6. Step 6: Assemble a Technical file.
  7. Step 7: Affix the CE Marking to your product.
  8. Step 8: Create the Declaration of conformity.
  9. Step 9: Keep Posted on updates of Standards that might affect your product.


Which standards applicable for presses?


Here Are Three Types of Presses:

  1. 1. Hydraulic presses
  2. 2. Mechanical Presses
  3. 3. And Pneumatic Presses


Standards Applicable for Presses:


  1. 1. EN 693:2001 +A2:2011 standards applicable for Hydraulic Presses
  2. 2. EN 692:2005 +A1:2009 Standards applicable  for Mechanical Presses
  3. 3. EN 13736:2003 +A1:2009 for Pneumatic Presses.


Our Service Include: 

  1. 1. Technical Guidance
  2. 2. Documentation Guidance
  3. 3. On-site safety testing from NABL, BIS lab against EN60204-1, 
  4. 4. Pre-audit and CE certification from a notified body.


If you are interested to Get CE Certified your Hydraulic Equipment, Please Send us the following information to quote you:

  1. 1. Name of product
  2. 2. Product photograph
  3. 3. Intended use of the product
  4. 4. 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


People also ask:

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  • What are the documents required to prepare respective files for CE?
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  • Can we start marking "CE" on our Hydraulic Equipment based on the above test reports?


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Thursday 24 June 2021

What Are The Requirements of CE Marking Certification for LED Lights?

Requirements of CE Marking Certification for LED Lights

What Are The Requirements of CE Marking Certification for LED Lights?

CE Marking is the most important Certification and  Passport for a product to sell in the European Market. if LED manufacturers have a CE certification mark, they can easily sell their products in European Countries.

What Certification does LED lighting need to pass in order to enter the European market?

It is not a difficult question to answer, which Certification need to pass in order to enter European Market

Here is Four Directives Required for CE Certification to Enter the European market:

  1. LVD Low Voltage Directive (2006/95/EC 9 2014/35/EU)
  2. EMC Directive (2004/108/EC 9 2014/30/EU) 
  3. EcoDesign Directive   (2009/125/EC)
  4. RoHS Directive  (2011/65/EU) 

Is CE Certification Mandatory for LED lights?

Yes CE Certification is mandatory for LED lights, but CE Marking can be carried out by so many Certification bodies and labs, And so many certification bodies and labs are not so serious about their work.

So if you have enough budget, we will recommend getting our Certification and testing services, we have one of the most reputable testing and certification bodies in the world.

What do we need to Sell LED lighting Products in Europe?

The CE marking certification symbolizes the conformity of the product with the applicable Community requirements imposed on the manufacturer.

The CE marking certification affixed to products is a declaration by the person responsible that: 

  • The product conforms to all applicable Community provisions, and 
  • The appropriate conformity assessment procedures have been completed

How to Get CE Marking Certification for LED Lights?

Here are the 6 Steps To Get CE Marking Certification for LED Lights:

  1. Identify Directives & Regulations Applicable 
  2. Identify Applicable Standards
  3. Perform Testing according to Standards
  4. Complete The Technical File satisfying the requirement
  5. Write and Sign the Declaration of Conformity
  6. Apply the CE Mark

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

CE marking from Experts - with Testing and certification
CE marking for Medical Devices - for Machinery/ Pressure / Electronics /Electrical products
If You Have Any Requirement For CE Certification?
Please feel free to contact us
Mr. Puneet Sharma
+91-8196980555 - 07986633030 
Contact on Whatsapp https://wa.link/6lbssb 

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  • We have NABL accredited 3rd Party Type Test Reports for some of the LED Lights as per IS 10322.  Are these reports sufficient for CE certifications?
  • How do you evaluate LED lights?

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Thursday 22 April 2021

CE Certification for Aluminium and Steel Structures Products


How To Get CE Certification for Aluminium and Steel Structures Products?

Are You looking for a CE Certification of Aluminium and Steel Structures Products?

If you are searching for a CE Certification body for your Aluminium and Steel Structures Products, then you are at the right place, we will provide you CE Certificate for Your Products.

Get CE Conformity for steel aluminium structures and access the entire European market

Metal structures are used in construction works to provide mechanical strength, stability and fire resistance. All structural components and structural kits shall comply with the requirements of EU Construction Products Regulation No. 305/2011 for the CE Marking Certification 

The assessment of steel structures and aluminium structures is regulated under the system of assessment 2+, which requires the intervention of an (NB )Notified Body to carry out the initial audit and follow-up inspections of the FPC Factory Production Control.

Manufacturers or their representatives in the EU European Union are solely responsible for ensuring their products comply with the provisions of the Regulation, both for their marketing and use. When a manufacturer identifies a product with the CE mark Certification, this shows that the product complies with the harmonized standards and therefore fulfils the essential requirements of the Regulation.

CE Certification Process for Aluminium and Steel Structures Products:

We have a (NB) Notified Body for CE Mark of Aluminium  Steel components and we work with manufacturers throughout the entire CE Marking Certification process of their products.

The CE Mark Certification of structural components or kits is based on the following harmonized standard:

EN 1090-1 Execution of steel structures and aluminium structures - Part 1: Requirements for conformity assessment of structural components.

The CE Certification based on the above-mentioned standard defines a number of tasks to be performed, some by the manufacturer and others by the NB Notified Body, depending on the system of assessment:

Benefits of CE Certification for Aluminium and Steel Structures Products

  • Market your product throughout the European Union.
  • One-stop-shop for your characterization testing and factory production control audits.
  • Optimize control over your product and process, thus reducing costs due to non‑quality.
  • Improve precision and homogeneity in the technical measurement values of your products and transmit them clearly to your customers.

CE Marking documents for Aluminium and Steel Structures Products:

  • Declaration of Performance Manufacturer.
  • CE marking and labelling of the product Manufacturer.
  • Certificate of Conformity of the (FPC) Factory Production Control Notified Body, where relevant.

We have over 20 years of experience in performing inspections of construction products. We have carried out thousands of tests, certifying thousands of products for companies in India and across Europe

Aluminium and Steel Structures Manufacturer responsibilities for CE Certification:

  • To perform Type-Testing in accordance with annexe ZA.1 of the harmonized standard.
  • To implement a Factory Production Control at the company's facilities.
  • To establish a follow-up testing program specifying types, frequencies, etc.

Responsibilities of the Notified Body for CE Certification of Aluminium and Steel Structures Products, when applicable:

  • To perform the initial inspection of the Factory Production Control, assessment and acceptance.
  • To perform annual monitoring and assessment inspections.


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

CE marking from Experts - with Testing and certification
CE marking for Medical Devices - for Machinery/ Pressure / Electronics /Electrical products

If You Have Any Requirement For CE Certification?
Please feel free to contact us
Mr. Puneet Sharma
+91-8196980555 - 07986633030 

Contact on Whatsapp https://wa.link/6lbssb 


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Thursday 15 April 2021

GET CE Certification for External Stormwater Drainage and Stainless Steel Drain Grating

CE Certification for External Stormwater Drainage and Stainless Steel Drain Grating

GET A CE Marking Certification for External Stormwater Drainage and Stainless Steel Drain Grating 

Are you looking for CE Marking Certification for External Stormwater Drainage and Stainless Steel Drain Grating, if yes, then you are at the right place, We will provide you CE Certification for Your Products.

How to Get CE Certification for External Stormwater Drainage and Stainless Steel Drain Grating?

Here are the SIX Steps for CE Marking Certificate for External Stormwater Drainage and Stainless Steel Drain Grating:

1. Find the CE Certification directives that apply to your products.
2. Know the essential requirements for your products.
3. Determine if you need Third Party Inspection and certification.
4. Assess product conformity.
5. Create and maintain technical file documentation.
6. Declaration of Conformity and affix the CE Marking.

What is CE Marking Certification?

CE Marking Certification is an administrative marking that indicates conformity with health, safety, and environmental protection standards for products sold within the EEA European Economic Area. It is not a quality indicator or a certification mark.

Many products require CE Certification before they can be sold in the EU. CE Mark indicates that a product has been assessed by the manufacturer and deemed to meet European Union safety, health, and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU.

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 - 201304,

CE marking from Experts - with Testing and certification
CE marking for Medical Devices - for Machinery/ Pressure / Electronics /Electrical products

If You Have Any Requirement For CE Certification?
Please feel free to contact us
Mr. Puneet Sharma
08196980555 - 07986633030 

Contact on Whatsapp https://wa.link/6lbssb 


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Get CE and CSA Certification for Automatic Thermal Laminating Machine

CE and CSA Certification for Your Automatic Thermal Laminating Machine

Get CE and CSA Certification for Your Automatic Thermal Laminating Machine 

Are you looking for CE and CSA Certification for Automatic Thermal laminating machine, if yes, then you are at the right place, We will provide you CE & CSA Certification for Your machine?

If You Have Any Requirement For CE and CSA Certification?
Please feel free to contact us
Mr. Puneet Sharma
08196980555 - 07986633030 Contact on Whatsapp https://wa.link/6lbssb Email: CE.Marking.Certification@Gmail.Com
CE marking from Experts - with Testing and certification
CE marking for Medical Devices - for Machinery/ Pressure / Electronics /Electrical products
https://cemarkingexperts.wordpress.com/

How to Get CE Certification for Automatic Thermal laminating machine?

Here are The 5 Steps for CE Certificate for Automatic Thermal laminating machine:

  1. Identify All Directives- More than one directive may be applicable — APPLY TO NOTIFIED BODY 
  2. Identify Generic or specific Standard ( EN standards - Harmonised) 
  3. Get your machine Tested 
  4. Compile a Risk analysis as per EN 12100 and a technical File 
  5. GET THE CE CERTIFICATE FROM NOTIFIED BODY 

What is A CSA Certification?

CSA Certification is Canadian Standards Association, You can get Canadian market access through CSA Certification, The CSA is a standards organization that develops standards in 57 areas. CSA publishes standards in print and electronic form and provides training and advisory services. CSA is composed of representatives from industry, government, and consumer groups.




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