Who we are & what we do

The Medical Devices Division is committed to the application of specialized non-invasive therapies for Interventional Cardiology & Radiology procedures by applying state-of-the-art technologies in research & development, production and packaging. We additionally manufacture disposables for Nephrology, Urology, Liquid Administration and Anesthesiology.

Recently our company has entered the Back-Pain sector with a similar approach.

On top of the manufacturing of products with the “Rontis” brand-name, we can also provide OEM services along with custom-made solutions and multiple product configurations. The complete offering is available from both of our manufacturing sites in the towns of Larissa & Veles.

Core Pillars

The following have been identified as the core Rontis pillars of the complete medical device inception, R&D and manufacturing processes applied:

  • Invent and design specialty products of the highest quality & technology incorporated
  • Continuously improve internal quality control system, in order to ensure excellent product safety & performance
  • Respond quickly to market’s & business partners’ expectations
  • Ensure scientific and technical support from key opinion leaders in the medical device field.

Quality

Our plants are certified according to ISO 13485, ISO 9001, GMP (Good Manufacturing Practice) and all products bear a CE Mark. The certification is being conducted by DEKRA (Germany).

R&D

Following closely our philosophy that is based on the key principles of Innovation, Quality and Service, our mission is to offer to healthcare professionals, as well as the wider public across the world, innovative solutions for their daily healthcare needs.
Rontis is present in a wide array of healthcare industry business segments and therefore aims to apply continuous research and development, to design, produce and offer optimum solutions, whether it is a specialty product or a service, in all fields that our company is involved in.

Production

Our products are manufactured according to the European Medical Device Directive and to all required International Standards (ISO Standards). The clean rooms are class 10.000 with temperature and pressure online control, according to the EC Guide to Good Manufacturing Practice.

State-of-the-art production equipment are used and are supported with high precision and accurate automations in order to ensure the quality and continuity of the products.

An 100% strict quality control is performed for every product at every step of the production This is achieved by using validated equipment and processes as defined by International Standards.

The raw materials we use are supplied by top European and U.S. Medical Suppliers. All necessary safety sheets depicted by International Standards are provided and they ensure their quality and usage in medical devices.

Final products’ quality control is performed as defined by the ISO Standards and these include:

  • Sterility Tests
  • ETO Residuals
  • Bioburden Controls
  • LAL Tests (Pyrogenicity)
  • Technological Controls
  • Balloon Compliance Tests
  • Dimensional Tests
  • Chemical Tests
  • Mechanical properties Tests
  • Accelerated Aging studies
  • Stent Dislodgment Test
  • Air particles counting
  • Others

All of our products are biocompatible, hemocompatible, toxic free, examined for cytotoxicity, carcinogenicity and genotoxicity controlled by external Laboratories certified by GLP.