CE Marking :: for BEMER Classic and BEMER Pro Set

The BEMER Classic and Pro sets have been given the CE marking pursuant to the EU directive 93/42/EEC for medical devices.

The main purpose of his marking is to guarantee end consumers safe products within the European Union and it functions more or less as a “passport” for the European market.

By affixing the CE marking, the manufacturer confirms that the product in question complies with the specific EU directives.

In order to obtain the CE marking for medical devices such as our BEMER sets, several conditions must be met, including the following:

• The product must have a proven medical benefit.
• The product must have been proven to be safe for the patient, user, and third parties and remain so during use. No deterioration may arise during the entire life cycle of the product.
• The product must comply with all applicable legal requirements.
• The manufacturer is monitored by the responsible authority.
• Extensive “technical documentation” is required to verify compliance with all applicable requirements.
• The manufacturer is obligated to conduct market studies.

With respect to our BEMER Classic and Pro sets, we have easily complied with all of these conditions and of course, we will continue to comply with them.

For us as well as our customers, this yields the following benefit:

The CE marking can be viewed as a seal of quality and is recognized not only in Europe, but in many other countries as well.

This marking again emphasizes the medical quality of the BEMER sets and allows us to become increasingly established in the international market.

ISO-Certificate :: for BEMER Int. AG

BEMER Int. AG is DIN EN ISO 13485:2010 certified.

This standard deals with the requirements for quality management systems for the manufacturers of medical devices. An established and certified quality management system supports compliance with the relevant European CE directive for medical devices.

Certification confirms the following conditions are complied with:

• The standard must be implemented within the entire organization.
• All applicable requirements of a medical device must be fully complied with.
• Extensive quality control including suppliers must be ensured.
• For assembly, inspection, shipping, and service, proven and thus optimized processes are to be used.
• Only trained and verifiably qualified personnel may be employed.

BEMER has always set the highest standards regarding the excellent quality of its products and work processes and this is also confirmed by this certification. It goes without saying that we will not only maintain this level but ‒ as far as possible ‒ even improve on it for us and for our customers.