Certain products require CE-marking to be sold within the European market. By CE mark you declares that your product complies with the essential requirements of the applicable EU Directives.Applicable requirements are set forth in various European Directives that replace individual country safety standards. The Directives apply to products manufactured within but also exported to the European Union.
The requirements of the CE can be divided into two major categories:
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1. Quality system Requirements, with which the manufacturer should comply, regarding the development and the manufacturing of the product.
2. Safety and reliability requirements the product should meet, which includes items such as biiocompatibility, software validation, ellectrical safety, ellectromagnetic compatibility (EMC), performance evidence, technical performance evidence, and pre-clinical and clinical evidence.
Let AIMS Management Consultants help you! A world leading consulting organization can provide you professional & reliable services.AIMS Management Consultants is a world leading consultancy organization specialized in global product & system certifications such as: US FDA compliance, UL mark; European Union & EFTA product safety requirement- CE Marking, ROHS compliance, China Compulsory Certification- CCC Mark, ISO standards, HACCP, OHSAS, C-TPAT, KAIZEN, GMP, EUREPGAP, Six sigma, SA 8000, BSCI, WRAP etc. De System has presence in India and other parts of Asia
We are having our presence in following geographical areas:NEW DELHI, CHANDIGARH, HARYANA -Panchkula, Faridabad, Gurgaon, Bahadurgarh, Bhiwadi, Panipat, UTTAR PRADESH - Ghaziabad, Kanpur, Allahabad, Lucknow, Agra, Meerut, Varanasi, Bhadoi, Rampur, Noida, UTTRANCHAL- Mandi, Baddi, GUJARAT - Ahmedabad, Surat, Bhavnagar MAHARASHTRA - Mumbai, Nagpur, Pune JAMMU & KASHMIR - Jammu, PUNJAB - Ludhiana, Faridkot, Amritsar, Chandigarh KARNATAKA - Bangalore, Tumkur, Mysore, TAMIL NADU - Chennai, Tirupur, ANDHRA PRADESH - Hyderabad, MADHYA PRADESH- Bhopal, ORISSA - Raurkela, Bhuwneshwar, Katak WESTBANGOL- Kolkata, Durgapur BIHAR- Patna, Gaya, JHARKHAND- Ranchi. Jamshedpur.
A world-leading consultancy offers you excellent services at very competitive prices!
We are having our presence in following geographical areas:NEW DELHI, CHANDIGARH, HARYANA -Panchkula, Faridabad, Gurgaon, Bahadurgarh, Bhiwadi, Panipat, UTTAR PRADESH - Ghaziabad, Kanpur, Allahabad, Lucknow, Agra, Meerut, Varanasi, Bhadoi, Rampur, Noida, UTTRANCHAL- Mandi, Baddi, GUJARAT - Ahmedabad, Surat, Bhavnagar MAHARASHTRA - Mumbai, Nagpur, Pune JAMMU & KASHMIR - Jammu, PUNJAB - Ludhiana, Faridkot, Amritsar, Chandigarh KARNATAKA - Bangalore, Tumkur, Mysore, TAMIL NADU - Chennai, Tirupur, ANDHRA PRADESH - Hyderabad, MADHYA PRADESH- Bhopal, ORISSA - Raurkela, Bhuwneshwar, Katak WESTBANGOL- Kolkata, Durgapur BIHAR- Patna, Gaya, JHARKHAND- Ranchi. Jamshedpur.
A world-leading consultancy offers you excellent services at very competitive prices!
AIMS Management Consultants is a ce mark consultant, ce marking either through ce mark notified bodies or through ce mark self certification. Being a ce mark provider we arrange service of authorized representative, make available all eu directives for ce mark, eu standard for ce marking & ce label. We provide conformity services against eu legislation. Preparing ce mark technical file, arranging ce mark testing services, ce mark inspection, ce mark compliance consultancy, preparing ce mark user manual, helping product placement in European union etc are services offered by your ce mark advisor (AIMS).Any eu directive for ce mark- EMC directive, low voltage directive or medical directive- we are here to help you out. Delhi, India or European union we are at your doorstep. Ce mark for cable, Ce mark for medical equipments, Ce mark for surgical equipments, Ce mark for electronic products, ce mark for construction products, ce marking for personal protective equipment, ce mark for pressure vessels, ce mark for gas appliances, ce mark for lift machinery, ce mark for measuring instruments, ce mark for marine equipment- what ever is the product just tell us. 'CE mark/CE marking your product's passport for European union'
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In order to get CE mark, you need to comply with one or more of the following requirements:
Establish and maintain a Medical Quality Management System
Test your product in order to demonstrate compliance with applicable standards
Prepare a Technical File / Design Dossier for each family of products that you wish to obtain CE mark.
Contract a European Authorized Representative.
Contract a Notified Body who will audit your Quality Management System and Technical Files / Design Dossiers.
Register your company and list your product with at least one European Competent Authority.
The actual requirements for your family of products are subjected to the classification of your devices. This classification is based on the level of risk your device contains.
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In order to get CE mark, you need to comply with one or more of the following requirements:
Establish and maintain a Medical Quality Management System
Test your product in order to demonstrate compliance with applicable standards.
Prepare a Technical File / Design Dossier for each family of products that you wish to obtain CE mark.
Contract a Notified Body who will audit your Quality Management System and Technical Files / Design Dossiers.
The actual requirements for your products are subjected to the classification of your devices. This classification is based on the level of risk your device contains.
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Establish and maintain a Medical Quality Management System
Test your product in order to demonstrate compliance with applicable standards.
Prepare a Technical File / Design Dossier for each family of products that you wish to obtain CE mark.
Contract a Notified Body who will audit your Quality Management System and Technical Files / Design Dossiers.
The actual requirements for your products are subjected to the classification of your devices. This classification is based on the level of risk your device contains.
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Product certifications like CE and FDA requires complying with Harmonized Standards and regulatory requirements by testing. Safe and effective while clinical trials, and other types of testing, are aimed at demonstrating the effectiveness of the product, there are other specific tests the product has to undergo in order to assure its safety. These tests should be performed by certified laboratories to prove that the device is safe both for the user and the patient.
In essence, the safety requirements, despite slight technical variations, are valid in all major markets - Europe, USA and most other countries. The tests applicable for your product will be tailored according to its nature.
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In essence, the safety requirements, despite slight technical variations, are valid in all major markets - Europe, USA and most other countries. The tests applicable for your product will be tailored according to its nature.
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for any query, please contact us at
AIMS Management Consultants
Vijay Garg :- 09212293916 / 09868301527
mail :- vijay@isoconnullsultantsdelhi.com
vijay@isoconsultantsindia.com
We are having our presence in following geographical areas:NEW DELHI, CHANDIGARH, HARYANA -Panchkula, Faridabad, Gurgaon, Bahadurgarh, Bhiwadi, Panipat, UTTAR PRADESH - Ghaziabad, Kanpur, Allahabad, Lucknow, Agra, Meerut, Varanasi, Bhadoi, Rampur, Noida, UTTRANCHAL- Mandi, Baddi, GUJARAT - Ahmedabad, Surat, Bhavnagar MAHARASHTRA - Mumbai, Nagpur, Pune JAMMU & KASHMIR - Jammu, PUNJAB - Ludhiana, Faridkot, Amritsar, Chandigarh KARNATAKA - Bangalore, Tumkur, Mysore, TAMIL NADU - Chennai, Tirupur, ANDHRA PRADESH - Hyderabad, MADHYA PRADESH- Bhopal, ORISSA - Raurkela, Bhuwneshwar, Katak WESTBANGOL- Kolkata, Durgapur BIHAR- Patna, Gaya, JHARKHAND- Ranchi. Jamshedpur.
A world-leading consultancy offers you excellent services at very competitive prices!
