Product Registration and Certification

As you must already know, all medical products that are proposed to be sold in the EU countries require pre-certification and the CE Mark Certificate prior to sale in Europe. In order to obtain the CE Mark, each medical company must also comply with Manufacturing standards of ISO 13485.

The CE Mark certification of your products and ISO 13485 must be completed by your company as a condition of our services to you.

If you do not already have these certifications and need our assistance we can help. If you already have them this is even better.