Thank you for considering to outsource your medical device project to Oscor. We love to design and manufacture medical devices for over 35 years. Most of our projects look simple, turn out often to be complex. We never give up which often results to be very rewarding for the patient, our customers and us. We want to partner with you for the long term. Thank you for trusting us.
When you choose your outsourcing partner, please consider the following.
|Over 35 Years Class III implantable device experience|
|Over 20 Years catheter and vascular introducer experience|
|Easy to work with management and engineering team|
|Dedicated and experienced program Management|
|One Source: Completely vertical integrated capabilities|
|Ready to use validated components and processes|
|Finished device OEM offerings|
|Fast customization with in-house tool and mold design|
|Dedicated first article pilot lines|
|Cleanroom manufacturing (Class 7 and 8)|
|Low cost offshore manufacturing|
|Over 10 Years in-house EO sterilization|
|Domestic and international regulatory experience|
|Highest industry and regulatory certifications|
Whether you are in the early development stage or have an established product design, Oscor is here to help you bring life-enhancing therapies to market – with maximum speed, control and cost efficiency. Ranging from minimal invasive to long term implantable Class III devices, Oscor offers complete product development and contract manufacturing solutions, and everything beyond:
With over 35 years experience and with product certifications in over 70 countries, Oscor is the industry leader in the design and development of minimally invasive and implantable medical devices. Having in stock and already validated components available with validated processes in place, allows us to offer customized turnkey prototyping and product development services, with shortest lead times, maximum control and minimum project risk:
To get your project at fastest time to market, while still complying to the ever changing regulatory environment, we offer you a dedicated and experienced team of project management, material, process and quality engineers, with dedicated cleanroom facilities. Saving time and resources by providing the services, technology, and staff you need to help maneuver through all steps of the project building process:
Located in the US, Germany and the Dominican Republic, Oscor offers over 150,000 sqft of ISO 14644-1 Class 7 and 8 certified cleanroom environment, dedicated for the manufacturing of minimal invasive and long term implantable devices. We have a formal technology transfer process and dedicated process engineer and quality engineering team to move your product from engineering and pilot line stage, and our from your existing manufacturing location, to our FDA registered and ISO 13485 certified manufacturing facilities.
Our Specialties include:
Oscor continuously strives to apply Lean Manufacturing and Continuous Improvement methodologies to help reduce your costs and improve production yields. Our Lean tools include:
Form single batch to automated high volume, Oscor offers in-house turnkey packaging and sterilization solutions for all your product needs. With over 35 years in-house experience in packaging of long term implantable devices and in-house EO sterilization, Oscor offers state of the art validated packaging and sterilization solutions. Fully validated, fast and low risk. With a total of 4 in-house EO sterilizers, Oscor’s ultra-modern facilities are dedicated to the sterilization needs of even most complex medical devices. Our fast, reliable contract sterilization program is the most comprehensive available:
Oscor has expertise and sells its own branded products in over 70 countries. With this we comprehensive support and regulatory services to bring your product to global market approval:
Oscor offers global supply chain and distribution management and support and services to minimize lead times and supply chain cost reductions:
Oscor offers an extensive line of ready to use components and in-house capabilities to speed your product development and product manufacturing process. Our experienced product development, process engineering, quality and regulatory team is anytime available to support your project, from prototyping to validated manufacturing transfer. By doing all critical process and components in-house, including mold and tool design, we can offer you product solution with maximum quality, control and cost efficiency.
|Design Verification Testing|
|Mold Design and Flow Analyses|
|Mold Making and Validation|
|Injection Molding Thermoplastic|
|Injection Molding LIM (silicone)|
|CNC / Swiss Machining|
|Laser Marking / Engraving|
|Nitinol Processing and Forming|
|Catheter Multi Layer Reflowing|
|X Ray Testing|
|Global Regulatory Consulting|
|OEM Branding of Finished Devices|
|Post Market Surveillance|
|Global Supply Chain Management|
|Customer Support Management|
|Global Distribution Network|
Being a finished device manufacturer for over 35 Years, Oscor is the industry-leading outsourcing partner for turnkey design and manufacture of minimal invasive implantable devices. We offer innovative solutions in the development of newest product platforms for:
Being a market leader in transseptal access, deflectable guiding sheaths, and EP diagnostic and ablation catheters, Oscor’s engineering, operations and quality team is ready to support and bring your electrophysiology device to market.
Having a wide area of validated connector, lead body and electrode components and processes available to give your implantable stimulation lead program a head start, we offer most innovative and cutting edge solution for your implantable neuro stimulation lead applications. Of course it helps to manufacture leads for over 35 years implantable leads, sold in over 70 countries. . Oscor’s experienced product development, operations and quality team can provide you cutting edge technology and innovative solutions for your custom product development project, in highest quality and shortest time:
With over 35 years of experience in the development and manufacture of minimal invasive catheter, introducer and implantable lead systems, Oscor’s product development, operations and quality team can provide you cutting edge technology and innovative solutions for your custom product development project, in highest quality and shortest time.
Oscor has long time expertise and offers highest innovative solutions for cardiovascular applications such as:
Oscor has extensive expertise in the development and manufacture or peripheral vascular devices. Oscor’s product development, operations and quality team can provide you cutting edge technology and innovative solutions for your custom product development project, in highest quality and shortest time.
Oscor has long time expertise and offers highest innovative solutions for peripheral vascular applications such as:
Oscor has extensive expertise in the development and manufacture of minimal invasive devices and delivery systems for structural heart applications. Oscor’s product development, operations and quality team can provide you cutting edge technology and innovative solutions for your custom product development project, in highest quality and shortest time.