Incentive

The conformity of medical devices according to the Medical Devices Ordinance (MedDO; SR 812.213) must be assessed before they are placed on the market. For most product classes, this requires the involvement of a Designated Body. SQS offers conformity assessments according to Annex IX and Annex XI (Part A) of the MDR. The evaluation includes an assessment of the technical documentation and the Quality Management System.

Outcome

If the conformity assessment is successful, you will receive the corresponding certificates, which are a prerequisite for the market approval within Switzerland.

Target groups

Manufacturers of medical devices with focus on the Swiss market.

Validity

5 years (restrictions possible) – in the sense of the continuous development, annual surveillance audits take place. After expiry of the certificate, a further recertification can take place.

Recognition

SQS is designated by Swissmedic under the identification number 1250.
The SQS certificates are recognised within Switzerland.

Combinations

The Medical Devices Ordinance can be combined with EN ISO 13485:2016.