29 November 2022 | Tuesday | News
Image Source : Public Domain
Medeologix, a Taiwan MedTech CDMO company announces its successful acquisition of three premier medical device manufacturing companies to form an integrated full function service group. The newly formed Medeologix family of companies, with a combined footprint of 90,000 sq.ft, offers one-stop services from conceptual design to high-volume production.
The three Silicon Valley companies, Mediballoon, MedeonBio and Second Source Medical, along with Medeologix with a mass production facility in Taiwan, form the vertically integrated services from medical tubing extrusion, balloon forming, catheter processing, final assembly to packaging and logistic services. Together, they work seamlessly to support their clients from concepts to quality finished medical products for the MedTech industry.
MediBalloon, established in 2016, is an expert in extruding medical tubing and developing medical balloons in different shapes and sizes using various thermoplastic materials including Polyurethane, Polyethylene, Polyvinylidene fluoride (PVDF), Polybutylene terephthalate (PBT), Polyethylene terephthalate (PET), PEBAX, and Nylons. The customer base includes startups and major OEM giants who seek fast turn-around time for their standard and complex balloon designs and catheter tubing.
MedeonBio, established in 2012, specializes in single and multi-lumen catheter processes, including braiding, coil winding, lamination, thermal fusing, tipping, balloon bonding and pleating, as well as hydrophilic coating. These catheters are commonly used in minimally invasive procedures for cardiovascular, neurovascular, peripheral and structural heart diseases.
Second Source Medical, established in 2004, is an FDA registered contract manufacturer with full FDA QSR and cGMP compliant for Class II and Class III PMA products, providing rapid response of integrated design and manufacturing services from component, functional prototype, subassembly, process development, verification and validation leading to pilot and mass productions in support of successful clinical trial, regulatory approval and commercialization. In addition to its 2,000 sq.ft clean room, Second Source Medical also houses a yellow lab to handle UV light sensitive liquid mixing processes as well as a Silicone forming lab.
Medeologix family of companies are ISO 13485 certified. The alignment of quality systems among each company and within the entire group provides seamless transition from concept stage to production scale up without costly re-validation and production delay, thus assuring their clients the most efficient services. In addition, the in-house expertise provides regulatory submission services for 510K, PMA and MDR, as well as help startups incubate their projects with virtual offices and quality system setup; a true major source for MedTech outsourcing solutions.