amg International GmbH develops, manufactures and sells on a world-wide basis stents, stent implantation systems and balloon catheters as well as auxiliary products such as guide wires and inflation devices, which are used primarily in the field of interventional cardiology. The company, which is headquartered 70km north of Düsseldorf in Raesfeld-Erle, Westphalia, Germany, was founded in December 1997. Over the years amg International GmbH became globally acknowledged for being specialized in manufacturing and marketing high quality products made of extraordinary innovative technology.
So, consequently according to amg’s vision and mission amg was World’s first enterprise having introduced to the market a coronary bare metal stent made of cobalt-chromium alloy, known as ArthosPico.
1998 OMEGA stent, MAC stent and their implantation systems
1999 MAC Carbon stent and coronary implantation system
Current products / technologies in the market
2001 Arthos Inert carbonized coronary stent
2002 Arthos Pico – cobalt-chromium (Co-Cr) coronary stent
2004 Thalis Inert – peripheral balloon expandable carbonized stent
2006 Pico Elite –paclitaxcel-eluting Co-Cr coronary stent
2007 MAC4 – stainless steel coronary stent
2007/08 – Angioflux / Easyflux – inflation devices
2009 ISTAR – PTCA balloon catheter
2010 ITRAC- coronary guide wire
2010 ICROS - carbonized coronary stent implantation system
2010 Facile - self-expandable peripheral nitinol stent
2012 ITRIX – rapamycin eluting coronary stent with biodegradable polymer
The establishment of this board gives essential input to research and development of projects and soonest upcoming products. The Advisory Board shall work alongside other global leaders to constantly innovate and improve the technology for better patient outcomes and ease of use. The board is formed from prominent opinion leaders and other interventional specialists in France, Germany, the Middle East, USA, Czech Republic, Australia, India, Italy, Spain, Korea, UK, Belgium, Greece, Netherlands & Austria.
Marketing and Distribution
amg International GmbH markets stents, stent implantation systems and balloon catheters in Germany through a dedicated sales force calling regularly on cardiologists in over 300 cardiology centres. Sales representatives are qualified medical product advisers and are all specially trained in the field of interventional cardiology, so that they can carry out qualified calls on cardiologists. This team is strongly supported by a customer oriented internal sales and customer service organisation which ensures that all customer enquiries are processed quickly and that orders are despatched the same day. International orders are sent by express currier, such as DHL, FedEx or UPS, and normally reach the customer within Europe on the next day after leaving the amg International GmbH warehouse at the latest. Clinical trials with experienced cardiologists are also important to collect information and observations on the performance of amg International products in the market, document efficacy and clearly demonstrate product advantages.
amg International GmbH worldwide
amg International GmbH is represented in more than 40 countries throughout the world by a network of amg subsidiary companies and experienced distributors. Marketing activities are focussed on a number of core geographical regions, such as Europe, Eastern Europe, Far East, Middle East, Asia, North Africa, South America and Australia. amg International products have already achieved considerable market share during the last twelve years and rank among the leading products in their segment, a result which demonstrates the strength of amg`s product development and marketing skills. Repeated presence at international exhibitions is one of the most important reasons for successful international expansion since entrance into the market. This has also contributed to amg’s reputation as a manufacturer of high quality and reliable products. The PCR in Barcelona, the European Society of Cardiology Meeting and German Society of Cardiology Meeting are just a few of the most important international congresses where amg International GmbH exhibited in 2009. The enterprise’s strategy of consistently strong growth through new product launches and geographical expansion will continue to be a vital success factor in future. amg International GmbH has already been successfully distributing its products for many years through partner companies in Russia, China and South-East Asia, and other growth markets, such as India, Argentine and Chile are being added all the time.
The Quality Management System (QM-System) of amg applies to all staff members, activities and products.
The following norms are implemented:
- EN ISO 9001:2008
- EN ISO 13485:2003 + AC:2007
- Guideline 93/42/EWG of the council dated 14th of June 1993 regarding medical products
The application and implementation of the norms and laws is the basis for maintaining the qualtiy aims defined by genaral management:
- customer satisfaction
- cooperation with capable contractors
- the efficiacy of the QM-system and the processes
- striving for continuous improvement
The QM department regulates and controls the compliance with norms and laws in the company by the following actions:
- internal audits, contractor audits, determination of performance data and management review reports
- product registrations - creation of the product main documentation in cooperation with our subcontractors
- continuous monitoring of the product quality and requirements, ensuring the trackability of every product
- maintaining and improving the internal monitoring and notification system
(for example, handling of complaints) and risk management
- guidance of documents and records
- initiation and control of corrective and pre-emptive measurements
"Regulatory Affairs" is directly linked to the QM department to conduct all administrative actions necessary to gain authorization from the authorities for development, production, sales and distribution of our products in the field.
The so-called approval of the products is performed on the one hand by our Notified Bodies (such as DEKRA Certification), on the other hand by our distributors and subsidiaries with the responsible authorities.