Certifications and Patents

Investment in innovation, research, and quality, in terms of products and working methods, continues to be a priority at ALPS. This is what allows us to offer the highest quality products and services at the best price.

This means that ALPS can guarantee the quality and safety of its products through certification from the most important internationally recognized institutions.

ALPS has been manufacturing FDA-approved medical devices since 1989.  ALPS products are designed and produced according to ISO13485 and GMP (Good manufacturing practice) standards, meeting the requirements of the EU regulations CEE 93/42 UE and conforming to MDR 2017/745.

ALPS Quality and Regulatory Compliance department is dedicated to maintaining the familiar high quality in every aspect of our business processes including providing support to all of our partners to make sure that every local and international regulatory requirement is met.

ALPS is characterized by its strong commitment to innovation and sustained investment in R&D. This has allowed the company to register more that 60 patents all over the world.

Certifications

ALPS Products Certifications

ALPS MDR CERTIFICATION
CE

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