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CE Marking

Baseefa provides services to help manufacturers to meet the requirements of a number of EU Directives and enable them to CE mark their products.

In addition to the ATEX Directive (94/9/EC), this includes:


Low Voltage Directive (2006/95/EC)

Electromagnetic Compatibility Directive (2004/108/EC)

Machinery Safety Directive (2006/42/EC)

Medical Devices Directive (93/42/EC as amended by 2007/47/EC)

The services include:

Training

Guidance through all phases of CE marking / documentation

Advice on the applicability and completeness of standards in support of the Essential Health and Safety Requirements of the Directive

Gap analysis and assistance for pre-compliance testing

Guidance in Risk Assessment and Management (ISO 14971)

Assistance with testing of your products as required by relevant Standards, by appropriate laboratories

Product assessment, reporting on compliance with relevant Standards and requirements

Certification to relevant Standards

Assistance with Technical File preparation

Evaluation of technical documentation for CE marking

Storage of Technical Files

Quality system service

Assistance with preparation and review of your EC Declaration of Conformity

We can provide a combination of these services which will allow you to identify, understand and comply with the legal requirements for CE Marking and for supplying your products into the EU.

Please contact anil.arora@baseefa.com to discuss how we can help you.

 


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