Thursday 4 August 2016

CE Marking for Valve Plate, Cushion Plate, Spring Plate, Valve Reed India

CE Marking for Valve Plate, Cushion Plate, Spring Plate, Valve Reed in India


CE Marking for Valve Plate, Cushion Plate, Spring Plate, Valve Reed in India

CE Marking for Valve Plate, CE Marking for Cushion Plate, CE Marking for Spring Plate, CE Marking for Valve Reed in India, Mumbai, Ahmedabad, Delhi, Chennai, Chandigarh, CE Marking for Valve Plate, what products need ce marking, ce marking self certification, ce marking exemptions, ce marking low voltage directive, ce marking requirements pdf, ce marking prototypes, ce marking one off products, ec new approach directives guidance
If you are looking CE Marking Certificate for Valve Plate, Cushion Plate, Spring Plate, Valve Reed, If your client Demanding For CE Marking, or If you want to Export your product in European countries. Eurotech Can Help you! Eurotech One of the Best Certification body Providing CE Marking for Valve Plate, Cushion Plate, Spring Plate, Valve Reed.
CE Marking Certification Expert Providing CE Marking Certification service on Valve Plate, Cushion Plate, Spring Plate, Valve Reed as per General Product Safety Directive (CE Mark-GPSD)

Kindly send us the following Details, So that we can provide you quotation for the same.

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

If Your Buyers Demanding for CE Marking Certification – Contact Now!
Mr. Puneet Sharma | Call: 08196980555 | Email: CE.Marking.Certification@Gmail.com
Get Instant Quotation! Please complete the Enquiry form below:


Full Name


E-mail:


Describe Your Requirements with Technical Details:


CE Marking for Valve Plate, Cushion Plate, Spring Plate, Valve Reed India

CE Marking for Valve Plate, Cushion Plate, Spring Plate, Valve Reed in India


CE Marking for Valve Plate, Cushion Plate, Spring Plate, Valve Reed in India

CE Marking for Valve Plate, CE Marking for Cushion Plate, CE Marking for Spring Plate, CE Marking for Valve Reed in India, Mumbai, Ahmedabad, Delhi, Chennai, Chandigarh, CE Marking for Valve Plate, what products need ce marking, ce marking self certification, ce marking exemptions, ce marking low voltage directive, ce marking requirements pdf, ce marking prototypes, ce marking one off products, ec new approach directives guidance
If you are looking CE Marking Certificate for Valve Plate, Cushion Plate, Spring Plate, Valve Reed, If your client Demanding For CE Marking, or If you want to Export your product in European countries. Eurotech Can Help you! Eurotech One of the Best Certification body Providing CE Marking for Valve Plate, Cushion Plate, Spring Plate, Valve Reed.
CE Marking Certification Expert Providing CE Marking Certification service on Valve Plate, Cushion Plate, Spring Plate, Valve Reed as per General Product Safety Directive (CE Mark-GPSD)

Kindly send us the following Details, So that we can provide you quotation for the same.

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

If Your Buyers Demanding for CE Marking Certification – Contact Now!
Mr. Puneet Sharma | Call: 08196980555 | Email: CE.Marking.Certification@Gmail.com
Get Instant Quotation! Please complete the Enquiry form below:


Full Name


E-mail:


Describe Your Requirements with Technical Details:


Monday 1 August 2016

CE Mark Certification In 5 Steps | Gain Access to the European Market

CE Marking Certification in Five Steps | Gain Access to the European Market

If your Buyers Demanding for CE Marking Certification in India, Or If you want to export your product in European Countries or if looking for CE Certification Consultancy Services. Eurotech Certification Body Providing an easy guidance of CE Marking certification to help manufacturers and exporters Get their product CE Mark
CE Mark Certification is a mandatory legal conformity requirement for all products sold within the EU that fall within the scope of a CE mark directive. By affixing a CE Mark logo to a product and signing the Declaration of Conformity, a product supplier is declaring to the EU European Union authorities that the requirements of all applicable directives have been met. Depending on the directive, involvement of a EU (European Union) NB (Notified Body) may be mandatory or voluntary.

CE Marking Certification in Five Steps:

  1. Decide which Directives are applicable to your product
  2. Ensure your product is compliant with the applicable Directives by testing and apply the relevant conformity assessment procedures
  3. Compile and retain a technical file, which satisfies the requirements of the Directives
  4. Write and sign the Declaration of Conformity and keep the original with the technical file
  5. Apply CE marking to the equipment in accordance with the requirements of the Directive
CE Marking Certification is a mandatory legal conformity requirement for all products sold within the EU that fall within the scope of a CE Marking Certification Directive. By affixing a CE Marking Certification to a product and signing the Declaration of Conformity, a product supplier is declaring to the European Union authorities that the requirements of all applicable directives have been met. Depending on the directive, involvement of a EU Notified Body may be mandatory for certain types of products.
Eurotech Certification Body assists companies to demonstrate their products compliance with the requirements of applicable Directives, by offering testing & certification in line with these requirements.

CE Marking EU European directives:-

CE Marking EU Directives for Electricals, Electronics and Consumer Products:

  1. CE Marking LVD Low Voltage Directive (2006/95/EC)
  2. CE Marking Electromagnetic compatibility (EMC) Directive 2004/108/EC
  3. CE Marking Radio Equipment Directive (RED) Directive 2014/53/EU
  4. CE Marking R and TTE Directive 1999/5/EC (Radio and Telecommunication Terminal Equipment)
  5. CE Marking Energy-related Products ERP Directive 2009/125/EC
  6. CE Marking Toys Safety Directive 2009/48/EC
  7. CE Marking RoHs 2011/65/EU (Restriction of Hazardous Substances Directive)

CE Marking EU European directives for Machinery and Equipment:-

  1. CE Marking Machinery Directive 2006/42/EC
  2. CE Marking ATEX Directive 94/9/EC
  3. CE Marking Construction Products Regulation 89/106/EEC

CE Marking Medical Devices EU European directives:-

  1. CE Marking Active Implantable Medical Devices Directive 90/385/EEC
  2. CE Marking In-Vitro Diagnostics Directive 98/79/EC
  3. CE Marking Medical Devices Directive 93/42/EEC

If Your Buyers Demanding for CE Certification Services - Contact Now!
Mr. Puneet Sharma | Call: 08196980555 | Email: CE.Marking.Certification@Gmail.com

Get Instant Quotation! Please complete the Enquiry form below:


Full Name


E-mail:

Describe your Requirements:








Tuesday 19 July 2016

FSC Free Sale Certificate | Free Sale Certificate Medical Device India

FSC Free Sale Certificate India, FSC Free Sale Certificate, Free Sale Certificate Medical Device India

If you are looking for FSC Free Sale Certification service in India, Eurotech Certification Body can Help you! Eurotech one of the Best FSC Free Sale Certification Consultant in India, if your Buyers Demanding for FSC Free Sale Certificate, you can feel free to contact us. Call: 08196980555
Free sale certificate is basically a document for certain commodities like pharmaceuticals required in certain countries. This document particularly specifies the certification that the imported goods are normally & freely sold in the exporting country's open markets and are approved for export.
The WHO induced certification for Free sale certificate scheme on the quality of pharmaceutical products so that the imported pharmaceutical products should encounter a trust of safety, effectiveness & adequate quality.
Usually WHO certification scheme includes good practices in the manufacture & Quality control of drugs.
Free Sale Certificate Scheme should enroll UPTO date list of manufacturers complying with GMP by the exporting countries.
Health Authorities of exporting countries must have the issuance of batch certificate.

There are various WHO type certificate which includes:

  • Certificate of pharmaceuticals WHO (1975)
  • Certificate of pharmaceuticals WHO (1988)
  • Certificate of pharmaceuticals WHO (1992)
  • BATCH Certificate etc.

Sually FREE SALE CERTIFICATE processes various procedures:

Example: If any country wants to export any item like any food material so it should follow these processes:
Rural payment agency should produce certificates like is it suitable for human consumption and animal consumption as well.
Human consumption must provide assurance that the product they are exporting should be safe and approved. It should not provide any harmful effects on the health.
For Animal consumption again assurance must be there in order to provide product free from radioactive elements.
Several Requirements must be followed in order to attain certification of Free sale Certificate:-
Companies must submit copies of invoices showing the sale of each product so that if in future any problem arises due to any circumstances there must be a proper submission of copies.
Manufacturer must given a written declaration to prove that its product is safe, secured and approved.
Specification of country name must be there so that no problem could be raised in future.

Documents which need to be submitted for the FSC are:

Check or verification of payment, unless a credit on account facility has been set up with the HPRA.
Proof of manufacture in the form of a notarized document.
Subsequent changes to the product listing do not need to be notarized.
 A copy of the current notified body certificates for the relevant devices.
Applications of this free sale certificate include a Secretary who can issue export certification for goods for therapeutic use in humans with the guarantee of safe and approved products.
Sometimes inspection programs are conducted in this to inspect any mistake or doubt and in return it is good program to check whether all the things that are listed must be correct.
Validity for Free Sale certificate must be included as an important part and it is 5 years from the date of issue.
Free Sale Certificate is basically a good option for the imported countries as what they want to have they can demand with proper certification and safe sight approval.

If Your Buyers Demanding for FSC Free Sale Certification Services - Contact Now!
Mr. Puneet Sharma | Call: 08196980555 | Email: Meddevices.net@Gmail.com

Get Instant Quotation! Please complete the Enquiry form

all Us On0896980555

Friday 15 July 2016

CE Marking Certificate for Orthopaedic products

CE Marking Certification for Orthopaedic Products in India

CE Marking Certification for Orthopaedic Products in India

If you are looking CE Marking Certificate for Orthopaedic products, If your client Demanding For CE Marking Certification, or If you want to Export your product in european countries. Eurotech Can Help you! Eurotech One of the Best Certification body Providing CE Marking Certification for Orthopaedic products.

Kindly send us the following Details, So that we can provide you quotation for the same.

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

If Your Buyers Demanding for CE Marking Certification – Contact Now!
Mr. Puneet Sharma | Call: 08196980555 | Email: CE.Marking.Certification@Gmail.com
Get Instant Quotation! Please complete the Enquiry form

Wednesday 6 July 2016

11 Steps in the US FDA Medical Device Approval Process | US FDA Registration Process for Medical Devices India

US FDA Registration Process for Medical Devices

Eurotech And Meddevices Certification Body Providing US FDA Certification and Registration service in India. If your client Demanding for US FDA Certification Registration, you can feel free to contact us.
All The Manufacturers, Traders, Suppliers, Exporters companies planning to sell a Medical Devices in the United States of America need to register their product with the US FDA Registration. Most Class 1 devices can be self-registered but most Class 2 devices require a 510(k) submission. For Class 3 devices, a Pre-Market submission is needed. The steps below provide a brief overview of how the PMA & (Food and Drug Administration) FDA 510(k) process work. The chart shown illustrates the (Food and Drug Administration) FDA approval process in USA.

Step 1 US FDA Medical Device Approval Process

Using the (Food and Drug Administration) FDA classification database, determine the classification of your device by researching Predicate Medical Devices already registered in the US market. Pay special attention to the three letters Device/ Equipment Code and 7 digits Regulation Number associated with the predicate Medical Equipment you identify. If no predicate found, use 513(g) / De Novo process. US FDA Medical Devices classification is made up of Class I, Class II and Class III.

Step 2 US FDA Medical Device Approval Process

Implement QMS which meets the (Food and Drug Administration) FDA Quality System Regulation found in 21 CFR Part 820. This is also commonly known as (Food and Drug Administration) FDA GMP.

Step 3 US FDA Medical Device Approval Process

Innovative Class II, and all Class III, Medical Devices will likely require clinical studies. Get Pre-Submission feedback from the (Food and Drug Administration) FDA.

Step 4 US FDA Medical Device Approval Process

If clinical studies will be required, apply for an Investigational Device Exemption. Develop clinical trial protocol and conduct studies.

Step 5 US FDA Medical Device Approval Process

For Class II Medical Devices, prepare & submit 510(k) Pre-market Notification application. Pay 510(k) / PMA submission fee. For Class III Medical Devices, prepare & submit Premarket Approval application. Pay PMA submission fee to (Food and Drug Administration) FDA.

Step 6 US FDA Medical Device Approval Process

For Class III Medical Devices, (Food and Drug Administration) FDA conducts facility inspections of all major Manufacturers /suppliers/ Exporters involved in the design & production of your Equipment. All parties must be compliant with (Food and Drug Administration) FDA QSR.

Step 7 US FDA Medical Device Approval Process

For Class II Medical Devices, the FDA (Food and Drug Administration) issues 510(k) clearance letter & posts it online. For Class III Medical Devices, the FDA (Food and Drug Administration) FDA issues PMA approval letter & posts it online.

Step 8 US FDA Medical Device Approval Process

At this time, you must be in full compliance with QSRs. The (Food and Drug Administration) FDA will not inspect Class I or II Medical device Manufacturers /suppliers/ Exporters for compliance prior to device registration but does conduct random inspections and can issue a Form 483 for non-compliance..

Step 9 US FDA Medical Device Approval Process

If you have no local presence in the US, appoint an (Food and Drug Administration) FDA US Agent representative as a local point of contact with the (Food and Drug Administration) FDA..

Step 10 US FDA Medical Device Approval Process

List your Medical Devices & register your company using FURLS system on the (Food and Drug Administration) FDA website in accordance with 21 CFR Part 807 contract /suppliers/ Exporters & sterilizers must also register & list. Specify your appointed US Agent. Your (Food and Drug Administration) FDA Establishment Registration and Listing must be renewed on a yearly basis.

Step 11 US FDA Medical Device Approval Process

You are now able to sell your device in the US. The FDA (Food and Drug Administration) listing on their website will serve as your authorization to commercialize your device in the US. This authorization does not expire as long as certain types of changes are not made, e.g., design, intended use.

Please give 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.

If Your Buyers Demanding for US FDA Certification Registration Services - Contact Now!
Mr. Puneet Sharma | Call: 08196980555 | Email: Meddevices.net@Gmail.com

Get Instant Quotation! Please complete the Enquiry form below:

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Thursday 16 June 2016

CE Marking Process | CE Marking For Industrial Manufacturing | CE Certification Facility India

CE Marking ProcessHow to Get CE CertificationCE Certification CostCE Certification Facility India,CE Marking For Industrial Manufacturing India

If your Buyers Demanding for CE Certification Services - Contact Now!
Eurotech Certification Body can help you gain access into the European Countries by ensuring your product meets all CE Certification requirements. How a product complies with EU safety, health and environmental requirements, and how to place a CE Marking on your product.
Eurotech offering you a complete solution of CE Certification. CE Marking Certification allows you to legally Supply, Sell and distribute, Export your products throughout Europe by showing legal compliance to all relevant directives and regulations.

CE Certification Facility - From Eurotech Authorised Notified Body with full Technical File Guidance:

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If you are looking for CE Certification Facility in India, Eurotech Certification Body providing CE Certification Services

Please give 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.

Get Phone Numbers, Addresses and more for CE Certification Services - Contact Now!

Mr.Puneet Sharma | Call: 08196980555 | Email: CE.Marking.Certification@Gmail.Com

Get quote for CE Certification and Testing, Please Fill the Enquiry form

Saturday 11 June 2016

CE Marking for LED lights In India | CE Mark Certification for LED Lighting Products

Are you looking for CE Marking Certification Service for your LED Lighting Products?

Eurotech Certification Body Providing CE Marking Certification for LED Lighting Products, If your Buyers Demanding for CE Certification Services on LED Lighting Products, We Can Help, Eurotech Certification Body is providing complete solution for CE Certification required for LED Lighting Products . Applicable EU directive for the LED light product Low voltage directive 2014/35/EU. As per the Annex III of LVD test report as per the applicable harmonized IEC/EN standard is must requirements. without the test report Technical documentation would not be complete. As a safety testing is mandatory part , manufacturer must get the third party test report from NABL approved lab as per IE/EN 60598 standards.

CE Certification of products provides a substantial basis of demonstration that a product meets minimum standards of safety and performance ensuring protection of the end user and expected performance and reliability in normal use.

In European Countries we use CE Marking Certificate as the basis for demonstrating that mandatory requirements have been met.
European legislation for product certification specifies conformance assessment based upon the CE Marking Certification system.

CE Marking is attached to a product when there is a relevant European directive which mandates the expected minimum requirements for some aspect of the product’s construction or specification.  Manufacturer Company applying the CE Marking provides a declaration of conformity claiming that the product meet the requirements of the European directives (EU) and regulations & lists the key standards which have been supplied.

For LED Lighting products for use in general lighting applications the route for CE Certification is through self certification as shown in the diagram, which means that the manufacturer should declare conformance when they are confident the product meets the requirements.

European Directives of LED Lighting Products:

CE Marking of LED Lighting Products
LED Lighting products for general illumination purposes will be subject to the following key directives under CE Mark Certification :
  1. LVD (Low Voltage Directive)- 2006/95/EC
  2. 2014/35/EU from 20th April 2016
  3. EMC (Electromagnetic Compatibility Directive) - 2004/108/EC
  4. 2014/30/EU from 20th Apr 2016
  5. ROHS (Restriction of Hazardous Substances Directive) - 2011/65/EC
  6. ERP (Eco Design Directive) and relevant regulations - 2009/125/EC

What should be the content of technical file for LED Lighting Products:

  1. A general description of LED light product
  2. Manufacturing drawing , BOM , bought out certificate
  3. Basic description of operation of the LED light
  4. A list of the Directive & harmonized standard applied on to the LED light
  5. Results of design calculation , in-house test report , quality assurance plan
  6. Safety test reports from NABL lab

Technical File and Accreditation of Testing for LED Lighting Products:


It is often asked what accreditation is necessary for testing for CE Certification. The quick answer is that it is not a legal requirement that accredited laboratories provide the test reports.

However, the manufacturer/ Exporter Suppliers shall be required to ensure that their technical file can demonstrate that their product meets the relevant requirements of the EU European directives & regulations,

One way in which the manufacturer/exporter,suppliers is to have confidence it has met the requirements is to use test reports from accredited testing laboratories. Challenges by market authorities to any of the claims made about a products conformance may be more easily dealt with when an ISO/IEC 17025 accredited laboratory has been involved in the formulation of the test reports. We can do LED Lighting Products testing in our ISO/IEC 17025 accredited laboratory Electrical Safety Testing lab ITCIndia.

Declaration of Conformity for LED Lighting Products:

Declaration of conformity is the legal document which attests that the manufacturer is confident its product complies with the requirements of the European directives. It should only be signed by the company directors when there is sufficient information contained in the TECHNICAL FILE e.g. testing reports to back up the assertion of compliance in the normal route for applying the CE Marking through self-certification.


Please give 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.

Eurotech will provide further updates on the detail of CE marking for LED Products Lighting:

For More Information, Contact Now!
Mr. Puneet Sharma | Call 08196980555 | E-Mail: CE.Marking.Certification@Gmail.Com

Get quote for CE Certification and Testing, Please Fill the Enquiry form below:

Wednesday 8 June 2016

CE Marking | Machinery Directive | 2006/42/EC | CE Marking Assemblies of Machinery India

Are you looking for CE Certification Services for machine export? CE marking when is it required, what it means, and how to affix it.
If you are looking for CE Certification Services. Eurotech Certification Body Providing CE Certification Services for machine export. CE Marking Certificate is your ticket to Export your machine in (EU) European Market.
  1. How do we CE Marking Our Machinery?
  2. Do all new Machinery have to be CE marked?
  3. Does an assembly line have to be CE marked?
  4. I have modified my machinery. Do I need to re-CE mark it?
  5. What is a Declaration of Conformity for Machinery?
  6. Can I use my trading name on the DoC for Machinery?
  7. What is a Declaration of Incorporation for Machinery?
  8. Do replacement guards and safety components have to be CE marked?
  9. Can I demand information from the manufacturer's technical file for Machinery?
  10. If I make a product for my own use, do I need to CE mark it?
CE Certification is a process that allows manufacturers and Exporter to declare that their Machinery complies with all applicable European Community Directives. Declaration of conformity, issued by the manufacturer or its authorised representative, allows the product to be marked with the CE and offered for sale in the (EU) European Market. Machinery may not be offered for sale in the (EU) European Market without CE Certificate unless it falls within one of the Machine Directive exclusion categories. CE Certification according to the requirements of the Machine Directive is mandatory for machines offered for sale in the EU. Majority of the Directives that require CE marking cover the safety of the product. In the case of machinery, the principal Directive is the Machinery Directive (2006/42/EC). Since many machines contain electrical components or functions, the Low Voltage Directive and the EMC Directive may also be applicable and both of these directives contain additional requirements, which must be satisfied before CE marking can be applied.
CE Certification process is often relatively simple, but requires an interpretation of the requirements of the directives applicable to the product to be marked and, in the case of the Machinery Directive, a risk assessment against the applicable Essential Health & Safety Requirements. Manufacturers, or their authorised representative in the european union, should declare compliance of the Machinery to the requirements of the applicable directives before placing the CE Marking on it &, in so doing, takes legal responsibility for the Machinery . It is therefore important to have some documentary evidence of having interpreted the requirements of the relevant directives and evidence of testing to demonstrate conformity with these requirements.

Please give 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.

If your Buyers Demanding for CE Certification Services - Contact Now!
Get Phone Numbers, Addresses and more for CE Certification Services

Puneet Sharma | Call: 08196980555 CE.Marking.Certification@Gmail.com

Get quote for CE Certification, Please Fill the Enquiry form below:

Saturday 4 June 2016

CE Marking Diagnostic Products | CE Marking Medical Devices | CE Mark-MDD Class

CE Marking Certification For Diagnostic Products, CE Marking Medical Devices Eurotech

If you are looking to avail CE Mark Certification Service for Diagnostic Products. OR If your Buyers Demanding for CE Certificate on Diagnostic Products.
Eurotech Certification Body Providing CE Certification on Diagnostic Products as CE Mark-MDD Class I , Put our advisory, testing, and certification services to work for you and allow us to guide you through every step of the CE Marking process, CE Mar Certification allows you to legally market and distribute your product with in the European countries, and declares that, Get help obtaining the CE Marking Certification for your Diagnostic Products. We offer you CE Certification, Testing and CE Compliance Services in your Area.

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Please give 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.

Contact our specialists today.
Puneet Sharma | Call 08196980555 | CE.Marking.Certification@Gmail.Com

If you are Interested Please Fill Out the form to get quote for CE Certification: