Medtech made in Europe: Our Gruiu site is now ISO 13485 certified

Variosystems‘ Gruiu site in Romania has successfully obtained ISO 13485 certification, the internationally recognized standard for quality management systems in the medical device industry. This achievement reinforces the company’s commitment to delivering reliable, high-quality solutions for Medtech & Life Science applications.

Building on years of experience in the development and electronics production of medical technology solutions, Variosystems now also brings its Gruiu site in Romania up to the same high-quality standards, joining its already certified European sites in Steinach, Mendrisio, Zizers and Varaždin. The certification also strengthens the company’s capabilities in a strategic best-cost country location, combining efficiency with proven quality.

“Achieving ISO 13485 certification at our Gruiu site demonstrates our continuous focus on quality, compliance and innovation,” states Josipa Maršanić, Head of Quality & ESG. “It also reinforces Variosystems as a trusted electronics partner for Medtech companies across Europe.”

Delivering Medtech excellence:

• Trusted partner: Consistent compliance and quality across European locations
• Reliable quality: All processes meet risk-based approach cohering to international medical device standard requirements
• Faster delivery & scalability: Operations in a best-cost country enable efficient manufacturing
• Proximity to production: European footprint supports an efficient and resilient supply chain manufacturing
  

These achievements not only benefit our customers but also reflect the ongoing development and strengthening of the Gruiu site within European network of Variosystems. Since the 2024 acquisition of Schurter, the Romanian facility has been successfully integrated into Variosystems. In addition to the ISO 13485 certification, the site also recently achieved ISO 14001, ISO 45001 and ATEX certifications, reflecting commitment to quality, environmental responsibility and safety in the delivering electronics solutions.