From concept development to finished device, VistaMed is a leading provider of complex Extrusions, advanced Catheters & Devices to the minimally invasive medical device industry. Fully vertically integrated - VistaMed is 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. VistaMed offers a complete turnkey package, which includes design, extrusion, assembly, labelling, packaging, sterilization & regulatory certification.
VistaMed’s primary goal is to achieve complete customer satisfaction by consistently supplying products of the highest standards, on time & within budget. By continuously investing in the latest technologies, we ensure that our capabilities remain best in class, enabling us to adapt & provide for the ever changing/challenging needs of our healthcare industry partners. All our extrusion is performed in ISO 8 (Class 100k) 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 range of extrusions offering bespoke solutions to our customer’s requirements. We have also developed technology to provide full catheter or medical device assembly, testing, packaging, labelling (& regulatory services) in ISO 7 (Class 10k) cleanrooms.
VistaMed are at the forefront of manufacturing and R&D -enabling us to develop new and innovative treatment solutions in the exciting & constantly evolving medical device industry. As technologies and modality concepts develop, we at VistaMed must then adapt and change with them. Over the last 5 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 fast product development turnaround times. To complement our existing 80,000 sq. ft. facility an additional 40,000 sq. ft. extension will be opened summer 2017 adding additional capacity to our Class 7 & 8 cleanrooms. VistaMed offer our customers a “one stop” solution for the Design, Manufacture, Assembly, Sterilisation, Regulatory certification & Distribution of complex catheters. We have expertise & advanced capabilities in complex catheters for all areas of the body – be it - diagnostic, 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.
ISO 13485:2003 ISO Certification 14001, FDA registered manufacturing site Class 7 and 8 Cleanrooms that ISO 14644 certified VistaMed’s Quality System also takes into account: • the European Medical Device Directive 93/42 – EEC • the FDA’s QSR – 21 CFR Part 820
• Medical Devices
• Large Medical Device Multinational Companies • Small and Medium Sized Companies.
• Freudenberg Medical
Belgium, Netherlands, Luxembourg, Brazil, China, Czech Republic, Denmark, England, Wales, France, Germany, India, Israel, Ireland, Italy, Japan, Malaysia, Norway, Poland, Puerto Rico, Singapore, South Korea, Spain, Sweden, Switzerland, Tunisia, Turkey, United States of America (USA)
IDA Business & Technology Park Carrick-on-Shannon Co Leitrim
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