We’re in this together, and that includes getting essential medical device products out the door to global OEMs and end users timely and efficiently. Looking for an outsourced medical device contract manufacturing partner?
Meet Genesis Plastics Welding
Genesis Plastics Welding is an Indianapolis-based ISO 13485:2016 certified contract manufacturer. We provide radio frequency (RF) welding and heat sealing contract manufacturing of thermoplastic products for medical, military and other niche industries. We are proud to be three decades strong in bridging the gap for global medical device OEMs.
Unmatched Expertise Enabling Medical Device Innovation
Our unmatched expertise enables medical device innovation through collaboration. As a contract manufacturing solution provider, our experienced engineering and manufacturing team is well-versed in the manufacture (and assembly) of these in demand medical device products:
- Surgical Products
- Temperature Management Products (Surgical & Equipment Temperature Control)
- Infection Prevention Products
- Oxygen Hoods
- Medical Fluid Bags & Collection Pouches
- Bioprocessing Bags
- Cryogenic Storage Bags
- Ventilator Components & Assembly
Class 7 Medical Clean Room Manufacturing
Additionally, we have Class 7 Medical Clean Room manufacturing available around the clock depending on production demand. We meet FDA requirements for contract manufacturing of Class I, Class II and Class III medical devices and components. Our ISO 13485:2016 certified quality system is compliant with Medical Device Quality System Regulation 21 CFR 820 for Class I, Class II and Class III medical device and component manufacturing. We ensure tight control to your production specifications.
Outsourced Medical Device Contract Manufacturing
Amid this crisis, if you find your team needing to outsource manufacturing to keep up with demand, make sure to properly screen potential contract manufacturing partners, scrutinize your options and choose a best-fit contract manufacturer for your niche needs. Our recent blog can help. As in a marriage, taking the time and care to find your best fit can save you a lifetime of grief.
OEMs, have a brand new life-saving device to launch? Our design and development division’s proven a product development process can strategically takes you from initial concept to commercialization with the human factor in mind, all while overcoming design hurdles and mitigating risks. Learn more.