ISO Med
ISOMed is specialized in disposable medical devices for vascular access. Since 1990, we propose therapeutic solutions in vascular surgery, oncology and digestive surgery. Our products meet the technical requirements practitioners demand everywhere in the world, the norms regulatory organizations set as well as the level of comfort. We are a small scale international company founded in 1990 and located near Paris. We are specialized in the design and production of medical devices. Our products are distributed in over 30 countries throughout the world.
Company details
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- Business Type:
- Manufacturer
- Industry Type:
- Medical Equipment
- Market Focus:
- Globally (various continents)
Who We Are?
We produce medical devices in three areas:
- ONCOLOGY under the FB Medical trademark, since 1990.
- VASCULAR SURGERY under the ISO Med trademark since 1994.
- DIGESTIVE SURGERY under the ISO Med trademark since 2000.
Our orientation towards international markets is the result of both an observation and a will: distributing our medical devices towards different practitioners in difference countries will enhance their effectiveness and economical efficiency.
This position allows us to constantly improve our medical devices, to set up new solutions and to enhance the quality of our service.
Last, the size of our production tool and our organization allow us to control our costs and to set the price of medical devices as low as possible, in order to treat as many patients as possible.
Today ISO Med has ambitious projects for the future and offers high quality products. We wish to develop our distribution network and be a reference in the healthcare industry.
Quality
As a medical sector company that is willing to maintain a high level of requirement, we put quality at the center of our concerns.
We see quality as a way to open ourselves to our clients, to listen to their needs and to answer them. We are willing to improve the efficiency of our products in order to accompany medical progress.
We aim at satisfying our clients, health practitioners and patients through a permanent offer of products and services that are adapted to their needs and expectations, and that take into account their economical constraints.
This is why our company is certified under the ISO 9001 and ISO 13485 norms. We see both of these international norms as a basis to set our level of expectancies in terms of products, services, processes, traceability, materials and systems, as well as in terms of good practices in order to evaluate conformity, management and organization.
ISO Med products have been strictly controlled and meet the criteria of the 93/42 EEC directive. Hence, they can use the CE mark.
CE marking is closely linked to the ISO 9001 and ISO 13485 norms under which ISO Med products are certified, which yields a consistent quality system.
CE marking totally guarantees the products and its utilization safety, which means that ISO Med took into account every risk that could stem from its products, and acted so as to eliminate them.
Production Capacity
The skills of our staff as well as the quality of our tools allow us to master technologies of casting and of molding from a casting by injecting various materials, in order to produce the components needed to manufacture medical devices or casts in small, medium or large scale.
Production Moreover, assembling and finishing operations (hole punching, tip closing, tip forming, welding, marking printing...) are undergone under laminar flow in a controlled atmosphere zone. ISO Med also performs conditioning and sterilization in accordance with the statutory framework.
Production Quality control procedures are operated all the production process along, which allowed us to obtain ISO 9001 and 13485 certifications, CE mark as well as to succeed in the audits performed by our clients. Vein Strippers We are constantly thriving to achieve excellence and economical efficiency.
Distributor
ISO Med produces medical devices that are adapted to the international market, which accounts for 60% of its sales. ISO Med products are now commercialized in more than 30 countries through an international distributing network.
ISO Med wishes to extend the distribution of its products to other countries, and to set up new partnerships with local distributors, in order to provide bulk as well as sterilized products.