• Over 25 years experience medical devices
• Highest industry certifications
• CEO commitment
• Privately owned
• Financial autonomy
• Structured for medical OEM
• Complete vertical integration
• Offshore manufacturing capability
• IP trustworthy
Talented Staff
Oscor experienced and talented team combined with state-of-the-art capabilities and impeccable reputation makes Oscor your most excellent choice when outsourcing.
Resources
Oscor offers in-house all the resources necessary to provide complete solution from product design to product launch and distribution.
Technology
Advanced simulation and fast prototyping tools complete device validation and qualification.
Oscor carries in stock many standard and validated components and subassemblies to speed up your product development and prototyping cycle. In addition our world class state of the art tool shop and engineering labs allow us to develop for you in shortest time prototype device for your first article evaluation and feasibility studies:
Less than 2 weeks
Less than 2 weeks
Less than 2 weeks
Less than 2 weeks
Less than 3 weeks
Less than 3 weeks
Less than 3 weeks
In stock
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Custom injection molds
Custom metal components
Custom prototype leads
Custom lead adaptors
Custom catheters (braid and coil reinforced)
Custom tubing
Custom cable assemblies
Medical hubs, connectors, fittings, packaging trays, lids and pouches |
Just contact us to see how we can fulfill your first article needs. As always, you will receive a cost proposal from us in less than 24 hours!
We offer a wide array of standard, validated and ready to use components to speed up your development project
•Peel away sheaths, standard high flex or high torque sheaths, custom sheath with multiple durameter, braid and/or coil reinforced sheaths
•Hemostatic valves, Tuohy Borst, check valves, sideports
•Coatings, custom tipping, pad printing, laser marking
•Steerable shafts, preformed shafts, soft atraumatic radiopaque tips
Typical development lead products include
•CS lead delivery systems
•Hemostatic valve introducers
•Diagnostic and guiding catheters
•EP catheters
•Stent delivery systems
We offer a wide array of standard, validated and ready to use components to speed up your development project:
•IS-1, LV-1, DF-1 & many custom connector, header & receptacle components
•Fixation mechanism (tines, retractable screw-in, suture-on, etc.)
•Lead body (coaxial, radial, multi-lumen, coil or stranded wire) silicone & polyurethane
•Steroid (DSP) collars, ligature sleeves, stylets, packaging trays, vein picks
Typical development lead products include
•Active and passive fixation leads
•Epicardial leads
•Cuff leads
•Paddle electrodes
•Custom preformed shape electrodes
Oscor offers complete development solutions for many custom catheter applications.
Oscor performs all of it processes like extrusion, braiding, coil winding, tipping, pad printing, molding, machining, packaging, sterilization, testing etc. in house which allows complete project integration, management and fastest development timelines. For rapid prototyping Oscor has an experience catheter development team with its own engineering cleanroom.
Typical development projects include
•Delivery systems, guiding catheters and tunneling tools
•Steerable catheters
•Complete custom application for interventional cardiology, electrophysiology, radiology, urology and many other areas
Voted* under the top ten tool shops in the United States, Oscor is one of the most innovative and advanced tool and mold making laboratories.
Oscor's skilled team of mold designers and engineers utilize latest CAM and mold flow simulation software to guarantee optimal mold design, runner technology with highest quality and repeatability. Oscor molds are validated from our mold bench directly into the injection molding shop, where in-depth IQ, OQ and PQ are performed and documented.
Continuous innovation and never ending drive to perfection has made it possible for Oscor to design and manufacture the worlds smallest pacing and stimulation leads.
"We could not find a supplier which continuously would deliver tightest tolerance components in a short lead time. So we built a CNC swiss machining operation offering the best in precision swiss machining and quality assurance. Now we manufacture precision components in days!"
Due to its unparalleled combination of talent, experience and capabilities, Oscor offers every extrusion capability for the even most challenging catheter and device application.
Ranging from single and multi lumen extrusions to complex multilayer braid or coil reinforced catheter assemblies with hub and tipping requirements, Oscor offers it all in house, turnkey and at lowest cost.
All extrusion, molding, assemblies and packaging are performed according to QSR guidelines under certified 100k and 10k cleanroom environment—true to all facilities.
Oscor offers complete device and component verification and qualification testing according to EN, ISO norms and DIN standards.
Oscor performs a wide array of device verification tests in-house. With the ability to build specilaized test and automation equipment in-house, Oscor can build the the exact tooling to comply with all your custom verification and test requirements.
Our specialty is the injection molding of high precision and complex medical components for implantable devices in silicone and thermoplastics including insert molding and over molding. Oscor performs all of its molding in certified cleanrooms according to QSR and ISO guidelines for molding of medical components.
Oscor offers low cost molding at its Palm Harbor and offshore facilities in the Dominican Republic for maximum flexibility, short lead time while providing highest cost savings. Oscor uses only newest all electric injection molding machines for highest precision, repeatability and energy savings.
Oscor offers ETO sterilization services for your medical device:
▪ ETO sterilization with DMB-Sterivit-automatic sterilization units
▪ Certified, fully automated parametric release procedure with complete adsorption of residual gases allowing immediate implant after removal from sterilizer
▪ Short sterilization cycles and a product release within 24 hours
▪ Safe for drug coated and treated products, safe for personnel, environment friendly and low in ETO residuals thanks to low temperature (45°C) sterilization with 8% ETO (Ethyleneoxide gas)
▪ Custom product sterilization validation and packaging shelf life testing available
▪ Clean room production and packaging available
Contract sterilization
Sterilize your products in our state of the art sterilization facilities located in Florida and the Dominican Republic.
We are experienced in sterilization of medical device products and offer advice to meet your product needs and requirement for optimal safety and sterility.
Our goal is to provide superior customer service and to help our customers achieve the most efficient and cost-effective means of sterility in compliance with all applicable regulatory and statutory requirements
Please contact for us for further information at sterilization@oscor.com
All packaging operations are available in-house to reduce your work load, lead time while improving overall quality and product presentation. Oscor performs turnkey packaging solutions at its Palm Harbor and Dominican Republic operations, the perfect solution for your domestic US and international distributions needs. All packaging is validated according to FDA and ISO standards.
Oscor has it's own in-house marketing team to serve all of your packaging design needs. We have on staff a professional photographer with state of the art equipment specialized for high resolution catheter and device presentation - including it's own label and bar code design department.
Over 25 years experience in the development and manufacturing of implantable medical devices makes us an ideal partner for your Medical Device Outsourcing needs:
We offer a smooth transition from product development, short production runs all the way to high volume offshore manufacturing. All Oscor facilities are FDA registered and ISO 9001:2003 (EN 46091, ISO 13485, 13488) certified. We oblige the toughest regulatory standards, including US, Canada, EU and Japan. Oscor’s manufactured products are approved for sale in over 40 countries.
Continuously raising the bar for product quality and innovation, Oscor is proud to be a strategic supplier for many leading medical device companies. We want to be your partner.
Please contact us to find out how we can bring your product to market in shortest time at quality@oscor.com
