Why Choose Oscor?

This is what we offer to you:

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.

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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
Quality Engineering
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
US Presence
EU Presence
China Presence
Brazil Presence
Privately owned

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:

• Design and Development
• Pilot and Clinical Built Support
• Assembly and Manufacturing
• Packaging and Sterilization
• Regulatory Services
• Distribution Management

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:

• Product design and development
• Rapid prototyping
• In-house mold and tooling design for fast customization
• Ready to use component for implantable leads, catheters, vascular access and introducer systems
• Human factor design
• Complete vertical integrated capabilities
• Robust and proven design controls compliant to the latest regulations
• Risk Analyses, DFMEA, PFMEA
• Ready to use PV and DVT protocols
• Process optimization
• Test system development
• Packaging design

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:

• Project dedicated Development and Process Engineers
• Full support of in-house Quality and Regulatory Team
• In-house technical support team to optimize production flow, tooling and process repeatability
• Dedicated cleanrooms for production pilot lines
• Clinical support

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:

• Silicone Molding (LIM)
• Micro Molding (LIM, PEEK, Thermoplastics)
• Insert and Overmolding (Thermoplastics and LIM)
• Multi-material molding
• Swiss machining
• Extrusion (multilumen, profile, bump-tubing)
• Braiding
• Laser welding, laser cutting , laser ablating, laser marking
• Coating
• Surface Treatment
• Tipping
• Nitinol forming and processing
• Bonding
• Reflow processing
• Pad Printing
• Centerless Grinding
• Swaging
• Finished device assembly and packaging
• In-house EO sterilization (ISO 11135)
• Final packaging and shipping

Lean & Continuous Improvement

Oscor continuously strives to apply Lean Manufacturing and Continuous Improvement methodologies to help reduce your costs and improve production yields. Our Lean tools include:

• US and Offshore manufacturing and supply chain optimization
• Process flow optimization
• Value stream mapping
• Statistical process control
• Automation
• Six Sigma / 5S
• DFMEA / PFMEA feedback and analyses

From 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:

Cleanroom Packaging:

• Packaging in certified ISO 14644-1  Class 7 and Class 8 cleanrooms
• US and offshore locations
• Low and high volume
• Single and complex kit packaging
• Pouch and bister tray thermos-sealing
• Packaging design and validation
• Automated packaging inspection systems
• Automated label inspection systems

Sterilization:

• 4x State of the art EO sterilizers utilizing 8% EO allowing 12 hour turnaround times
• Low volume and high volume chamber sizes available
• Sterilization facilities located in US and Dominican Republic
• Experienced and dedicated sterilization and validation team
• 24/7 customer service
• Quick turnaround
• ISO 11135 certified

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:

• US and EU Representative
• FDA Registered
• 510(k) and PMA device experience
• ISO 13485:2013 certified
• CMDCAS (Canada) certified
• JAPAN  accreditation as foreign manufacturer
• Australia Approved
• ISO 13485:9001 certified offshore facilities with identical equipment
• Manufactured according to directive 93/42/EEC and 90/385/EEC
• Post Market Surveillance Services
• Oscor Quality System is approved by the best industry leading medical device companies

Oscor offers global supply chain and distribution management and support and services to minimize lead times and supply chain cost reductions:

• US and EU Representative
• Quality System Integration
• Kanban
• I-Supply
• SMI (Supplier Managed Inventory)
• Consignment
• World Wide Distribution Management

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.

Here is what we specialize in:

Capabilities	Oscor
Product Design
Design Consulting
Rapid Prototype
Design Feasability
Design Verification Testing
Mold Design and Flow Analyses
Mold Making and Validation
Injection Molding Thermoplastic
Injection Molding LIM (silicone)
PEEK Molding
Insert Molding
Micromolding (<0.001g)
CNC / Swiss Machining
Centerless Grinding
Component Detailing
Laser Welding
Laser Marking / Engraving
Laser Cutting
Ultrasonic Welding
Nitinol Processing and Forming
Extrusion
Braiding
Catheter Multi Layer Reflowing
Tipping
Coating
X Ray Testing
Cleanroom Manufacturing
Kit Assembly
Turnkey Packaging
EtO Sterilization
Global Regulatory Consulting
Device Registration
OEM Branding of Finished Devices
Post Market Surveillance
Warehousing
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:

• Cardiac Pacing Electrophysiology
• Neuro Stimulation
• Cardiovascular
• Peripheral
• Structural Heart

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.

• Implantable stimulation and defibrillation (ICD) leads
• Subcutaneous Implantable Leads
• Implantable lead adaptors (low and high voltage)
• MRI compatible devices
• Leadless pacemaker delivery systems
• Deflectable guiding sheaths
• EP Diagnostic Catheters – Mapping & Ablation
• Ablation Catheter – Atrial fibrillation
• Introducer Sheaths – Fixed Curve, Steerable & Deflectable
• Transseptal Access Systems
• Lead Placement & Implantation Devices

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:

• Implantable Neurostimulation Leads
• Percutaneous leads
• Paddle electrodes and leads
• Cuff leads
• Vegal nerve stimulation leads
• Pain management systems
• Deep brain stimulation leads
• Implantable urology leads
• Implantable lead extensions and adaptors

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:

• Vascular introducers
• Diagnostic catheters
• Guiding catheters
• Deflectable guiding sheaths
• Micro catheters
• Central Venous Catheters
• Temporary pacing leads
• Pacing wires
• Balloon catheters
• Stent delivery systems
• Vascular closure devices

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:

• Vascular Access Introducers
• Peripheral Stent Delivery Systems
• Deflectable Guiding Sheaths
• AAA/TAA Stent Graft Delivery Devices
• Balloon Occlusion Catheters
• Aspiration Catheters
• Peripheral Ablation Catheters
• Vascular Closure Devices

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.

• Transcatheter Aortic Valve Replacement Delivery Systems
• Transcatheter Mitral Valve Repair Deliver Systems
• LAA Closure Delivery Systems
• PFO Closure Delivery Devices
• Introducer Sheaths
• Transeptal Access
• Sizing Balloon Catheters
• Occlusion Catheters
• Guiding Sheaths
• Steerable Sheaths
• Dilation Catheters