CE Mark Consultancy Bangalore

The following are the major reasons why a consultant is recommended for Medical Device CE Certification

1. Previous experience of certifying similar or related equipments /products
2. Documentation support including Technical File
3. Clinical Evaluation as per latest standard
4. Support in conducting Risk analysis
5. Internal Audit
6. Identify the Applicable Harmonized standards
7. Verify the test report
8. Verification of Validation documents
9. Label Review
10. Identifying the class of Medical Device
11. Finding the route of CE Marking
12. Prepare the Declaration of Conformity
13. Identifying the Notified Body
14. Support during Certification audit
15. Others like

ISO 13485 Consultants

Medical Device component manufactures, finished good manufactures, Medical Software developers, Medical Device designers and Developers and pharmaceutical suppliers interested in enjoying worldwide presence has to prove there devices are manufactured under certain auditable standards which means it’s safe and effective. ISO 13485:2003 Certification is a solution for this issue!!!

An ISO 13485:2003 compliant system expedites access into those countries that require it.ISO 13485:2003 Certificate will be issued by an accredited third-party after assesses your compliance towards Medical Device Quality Management System. We are there to help you in the training, documentation, implementation, and internal audit. You will be getting much useful information while you continue reading our web site.

CE Marking

It is a legal requirement. CE Mark is the manufacturer's claim that the Medical Device / Medical Product / Medical Equipment / Medical Device Component meet the essential requirements of relevant European Directives.

There are three European CE marking directives that specifically apply to medical devices manufacturers:

MDD 93/42/EEC + 2007/47/EC - The Medical Devices Directive applies to all general medical devices not covered by the Active Implantable Medical Devices Directive or the In Vitro Diagnostics Directive. 

Principles of the CE marking: 

• The CE mark shall be affixed only by the manufacturer or his authorized representative.
• The CE mark shall be affixed only to products which requires it as per European Community law, and shall not be affixed to any other product not included.
• Indicate a product's conformity with the "essential requirements" of the directives.
• By CE marking the manufacturer declares that he takes responsibility for the conformity of the product with respect to the Directive.
• Any other marking may be affixed to the product provided thus the visibility, legibility and meaning of the CE Mark are not thereby misrepresented
• Member States shall ensure the correct implementation and take appropriate action in the event of improper use of the marking.
• CE Marking for gaining access to the EFTA & European Union market. Ensure the "free movement of goods.