Technical file assistance
When applying the CE Marking to your product, proper documentation is required as a demonstration of proof that the product meets the applicable New Approach Directives. To provide manufacturers with a greater sense of confidence that this documentation is done correctly, Market Access Solutions provides the following services:
- CE Marking technical file compilation
Market Access Solutions will provide you with guidance documents that will assist you in properly constructing your CE Marking Technical File as required by many of the European New Approach Directives. Additionally, by working with our subsidiaries and partners, Market Access Solutions can also provide Notified Body or Competent Body intervention.
- CE Marking technical file review
In the case where you prepare your own CE Marking Technical File, Market Access Solutions staff will review technical documentation to assure that conformity is adequately demonstrated and that the file is complete.
For additional information
Should you have any questions on technical file assistance, require additional information, or wish to pursue any of our services, please contact us.
|