Concept

The Medical Devices Division is committed to the application of specialty 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 above offering is available at both of Rontis manufacturing plants: the first one located in the industrial area of Larissa, Greece as well as the second one located in Veles, Macedonia.

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

rontis-bulletInvent and design products of the highest quality & technology incorporated

rontis-bulletContinuously improve internal quality control system, in order to ensure excellent product safety & performance

rontis-bulletRespond quickly to market’s & business partners’ expectations

rontis-bulletEnsure scientific and technical support from key opinion leaders in the medical device field”

 

Our infrastructure & capabilities include:

rontis-bulletClean Room Areas: Class 7 (10.000) Grade

rontis-bulletElectromechanical Installations

rontis-bulletExtruders / Injection Molders

rontis-bulletPackaging (several types)

rontis-bulletSterilization

rontis-bulletResearch & Product Development Prototyping

rontis-bulletGood Scientific Practice / GMP

rontis-bulletQuality Control Laboratories

rontis-bulletRegulatory affair

R&D

We are geared to maintain intense focus on the research and development of new generation specialty products from conception to production.

Rontis is fully authorized for research and development activities which are being demonstrated through the portfolio of ours. On top of this, we can be your partner of choice in order to “take your product from concept through to design and development, prototyping and testing all the way to production, packaging and sterilization of semi and fully finished products”, while we have the know-how to guide you through to relevant regulatory procedures.

Working closely with prominent University Hospitals in the area of research and development has empowered us with the know-how to refine and manufacture effective, state-of-the-art technologies, some of which are unique throughout the world today.

The “Rontis New Product Designing” process includes the following:

rontis-bulletApplication Studies

rontis-bulletUpscale to production

rontis-bulletDevelopment and application of novel production methods

 

 

 

Quality

Dedicated to innovation and quality, we offer a new and wide range of choices to both the demanding healthcare professional as well as business partner of ours.

Quality is our commitment and our products are certified as per the following:

rontis-bulletEN ISO 9001:2008 Quality Management System

rontis-bulletEN ISO 13485:2012 QMS for Medical Devices

rontis-bulletCAN/CSA ISO 13485 QMS for Medical Devices

rontis-bulletTAIWAN EN ISO 13485 QMS for Medical Devices

rontis-bullet

Medical Device Directive 93/42/EEC, modified based on 2007/47/EC

rontis-bulletEuropean Union Guideline to GMP

rontis-bulletSOR/98-282 Canadian Medical Devices Regulations (CMDR)

rontis-bulletKFDA Standards for Manufacture and Quality Management of Medical Device (GMP)

rontis-bulletApproved from Saudi FDA, registered in Hong-Kong, Singapore, Brazil

 

Products

Rontis has developed over time the following product families:

Interventional Cardiology & Interventional Radiology Products

rontis-bulletDrug-eluting stents

rontis-bulletBare metal stents (both balloon-expandable and self-expanding)

rontis-bulletSemi-compliant, non-compliant, CTO and high-pressure balloons

rontis-bulletGuide-wires for both cardiology and CTO cases, applicable to PTA procedures as well

rontis-bulletA wide range of peripheral balloons and stents

 

Disposables Product Line

rontis-bulletLiquid Administration

rontis-bulletAnesthesiology

rontis-bulletUrology

rontis-bullet

Nephrology

 

Back-Pain Product Line

rontis-bulletKyphoplasty set

 

Our philosophy is to specialize in the above areas by offering innovative solutions and support our customers’ needs. Our state-of-the-art products are CE marked and approved by DEKRA, Germany.

The combination of a complete manufacturing system combined with logistics ideally located in the heart of Europe makes Rontis an ideal launch platform for medical devices.

We offer companies specializing in the sectors of Interventional Cardiology & Radiology, Nephrology, Urology, Liquid Administration, Anesthesiology & Back-pain, a broad range of opportunities for working in partnership as our exclusive distributors.

For additional information concerning our Medical Devices portfolio please visit our dedicated website www.rontismedical.com

 

 

 

 

 

 

 

 

 

 

Services

Today, we are handling exclusive projects for top global brands, manufacturing products under their own private label and according to their very unique technical specifications.

Rontis is an ISO Certified (DEKRA, Germany), full-service OEM Contract Manufacturer of minimally invasive interventional medical devices and medical disposables. We have developed our know-how based on the production medical devices that meet the requirements under ISO and CE of Good Manufacturing Practices.

Our production plants house EtO Sterilization Units, which include:

 

rontis-bullet2 preconditioning chambers

rontis-bullet1 main chamber / control room

rontis-bulletDegassing independent chambers which operate with continuous air recycling to reduce the EtO residuals

 

Rontis offers a full array of Laboratory Testing, which includes a Microbiological Lab, a Technological Lab and a Chemical Lab.