We are Authorized Body No. SKTC-113 and Notified Body No. 2265 for:
- Council Directive 93/42/EEC concerning medical devices as amended,
- Directive of the European Parliament and of the Council 98/79/EC on in vitro diagnostic medical devices as amended.
For a better overview of how the product certification takes place, you can consult the following chart: Flowchart of Conformity Assessment of MD IVD MD in NB2265.
In case of interest in our services in the field of Product Certification, please, send filled document "Questions for Quoting" via contact form.
If you are interested in our services, please, contact our office.