Home » About SSI Diagnostica Group » Extensive Quality Assurance

Extensive Quality Assurance

SSI Diagnostica takes pride in ensuring the best quality in our production facilities and finished products, as well as in our customer service and when providing instruction in the use of our products.

SSI Diagnostica’s development, production and sale of in vitro diagnostics is quality controlled and certified in accordance with ISO 13485. Products that fulfil the requirements of Council Directive 98/79/EEC of 27 October 1998 on in vitro diagnostic medical devices are CE-certified.

When we develop a new product, we always spend the time required to ensure that we launch efficient and user-friendly products to our customers. This means that our products have always been subject to field tests prior to being launched. When we sell a product, we offer training courses, to ensure the best understanding and use of our products.

Our customers’ opinions and experiences with our products mean a lot to us, as this is how we best develop and improve our products and procedures. Therefore, all inquiries, all praise and blame from our customers and users are registered and actively used.

ISO Certificate:
Download ISO 13485 Certificate

REACH Statements:
Download Safety Letter – IVD

Download Safety Letter – Culture media

Download Safety Letter – ImmuView

About us

We are a global company with ~600 employees, specializing in infectious disease diagnostics. We focus on gastrointestinal, respiratory, and bloodborne diseases, working every day to ensure better treatment outcomes through accurate and fast patient diagnostics.

SSI Diagnostica Group has scientific roots dating back to the early 1900s. We employ staff and operate offices in Denmark, the United States, and China, ensuring proximity to our customers and patients across all continents. Each year, we deliver diagnostic solutions in more than 130 countries, helping over 60 million people receive the right diagnosis and, ultimately, the right treatment as quickly as possible.

Vision statement: Be the global leader in making diagnostic expertise available to everyone. At any time. Everywhere.