VistaMed Ltd.

VistaMed Ltd.

VistaMed Ltd.

Business Description

From Concept Development to Finished Device, VistaMed, along with our Global Partner Freudenberg Medical is a leading provider of complex Extrusions, advanced Catheters & Devices to the minimally invasive medical device industry.

Vertically integrated – VistaMed, along with Freudenberg Medical, aim to simplify our customers supply chain and therefore provide a one stop shop for all your complex catheter requirements, from subassembly to a complete finished device, packaged, labelled & sterilised with full regulatory certification. We provide our customers with innovative catheter solutions enabling them to deliver leading edge technologies to the marketplace. We work with our customers in all phases of the design and development cycle to deliver complex catheter solutions to the medical device industry.

Products and Services

VistaMed, along with our Global Partner Freudenberg Medical’s primary goal is to achieve complete customer satisfaction by consistently supplying products of the highest standards, on time and within budget.

By continuously investing in the latest technologies, we ensure that our capabilities remain best in class, enabling us to adapt and provide for the ever changing/challenging needs of our healthcare industry partners.

All our extrusion is performed in ISO 8 (Class 100,000) cleanroom facilities. Our advanced capabilities enable us to produce extruded tubing with OD ranges from 0.2mm (.007”) to 20mm (.787”) and tolerances as low as +/-0.0065mm (0.0002”). Working with a wide range of thermoplastic materials such as PU/PEEK/ PVC/ PET/Nylons etc. we can produce a comprehensive range of extrusions offering bespoke solutions to our customer’s requirements.

We have also developed technologies to provide full catheter or medical device assembly, testing, packaging, labelling (and regulatory services) in ISO 7 (Class 10,000) certified cleanroom facilities.

Value Proposition

VistaMed along with our Global Partner Freudenberg Medical, are at the forefront of manufacturing and R&D – enabling us to develop innovative diagnostic or therapeutic treatment solutions in the constantly evolving medical device industry. As technologies and modality concepts develop, we at VistaMed must then adapt and change with them. Over the years VistaMed has invested in balloon blowing technology, hi-tech braiding instrumentation and “state of the art” extrusion technology to help our customers achieve their challenging device design and performance objectives. This along with our well proven expertise in innovative catheter solutions and device assembly has added further to our reputation as the preferred manufacturing partner in the hi-tech medical device market. Further to this we recently opened our off-campus catheter innovation centre which is a state of the art facility with dedicated engineering resources who are continuously pushing the boundaries of medical device design enabling us to offer these technologies to our customers. Here we have duplicate processing equipment and an extensive lab area (white room) for product prototype builds. This ensures accelerated product development turnaround times. VistaMed operates from facilities with a combined space of 120,000sq ft. with 10 separate cleanrooms which facilitates customer segregation.

VistaMed offer our customers a “one stop” solution for the Design, Manufacture, Assembly, Sterilisation, Regulatory certification & Distribution of semi-finished (components) and finished devices. We have expertise & advanced capabilities in complex catheters for all areas of the body – be it – diagnostic, therapeutic guide catheters, steerable devices, sensing or therapy delivery devices, VistaMed assists our customers through all stages of the product lifecycle. Our experience in innovative catheter design has enabled us to work with some of the largest companies in the hi-tech medical devices market and help provide design and manufacturing solutions on time, within budget & to the highest quality.

Standards and Certificates

  • ISO 13485 2016
  • ISO 14001 2015
  • Certs for our cleanrooms to ISO 14644

We do not get or have certs for the FDA but we are registered with the FDA.

Our QMS meets certain aspects of the MDD but again we do not get a cert for MDD compliance.

Sector(s) Served

Medical Device Sector

Key Clients

Large Medical Device Multinational Companies • Small and Medium Sized Companies.

Key Partners

Freudenberg Medical – who are a leading global supplier of silicone tubing and moulded parts to the medical device industry.

Geographical Market(s) Served

Benelux regions, Brazil, China, Czech Republic, Denmark, England/Wales, France, Germany, Holland, India, Israel, Ireland, Italy, Japan, Malaysia, Netherlands, Norway, Poland, Puerto Rico, Singapore, South Korea, Spain, ,Sweden  Switzerland, Tunisia, Turkey, United States of America (USA)

Address

IDA Business & Technology Park

Carrick om Shannon

Co. Leitrim

N41 N8C9

Ireland

Contact Details

071 9638833

WebSite

Email Company

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