A Turnkey Medical Device Outsourcing Partner for Single-Use Medical Devices
J-Pac Medical is the complete outsourcing partner for all your sterile medical device assembly, packaging, and sterilization.
J-Pac manufactures single-use, Class II & III sterile medical devices including, surgical devices, implantable textiles, and diagnostic consumables for both large and small OEMs. We manage your product realization through a robust ISO 13485 Quality Management System, giving you a complete medical device contract manufacturing solution.
The Right Medical Device Outsourcing Partner from Start to Finish
J-Pac recognizes that you are challenged to develop better products, achieve faster time-to-market, and lower total cost. Yet your resources are becoming more limited, requiring you to do more with less.
The back-end product realization processes required to launch a medical device are the single biggest cause of delays because they require complex and highly regulated processes that take more time than expected.
J-Pac’s medical device outsourcing model results in faster and less expensive product launches by executing the backend headaches of package design, sterilization validation, shelf life testing, and manufacturing scale-up in parallel to product design.
A Better Outsourcing Model for Better Results
Our expertise is in the back-end of product development. We know what needs to be done, how long it will take, and how it can be best integrates with your design process to reduce time and costs.
Dependable | Trustworthy | High Quality
Dependable, trustworthy, and high quality – these are the words our customers use when describing J-Pac. This is the result of our company culture, management leadership, and robust quality system.
Clear communication and collaboration are crucial to success. While you have a dedicated project manager who coordinates your program schedule, our experience has taught us that speed requires communication at multiple levels. We are an extension of your company and our process is designed to give you direct access to the hands-on people at J-Pac who get stuff done: engineers, quality specialists, and manufacturing management.
Medical Device Outsourcing Capabilities and Expertise
Unlike other medical device contract manufacturers, our capabilities and expertise are not beholden to any one medical device technology. Our expertise is applicable to most any single-use medical device.
- Experience serving large and small OEMs
- ISO 13485:2016 certified
- FDA registered
- Class 7 and 8 cleanroom assembly
- Dryroom for bioabsorbables
- Medical device packaging design and validation to ISO 11607
- Sterilization validation
- Shelf life validation
- Manufacturing IQ/OQ/PQ
- ERP traceability and lot control
- In-house tooling
- In-house package thermoforming
- 3D printing
- Manufacturing automation
- Supply chain management
- Lean manufacturing
- ERP system
- Broad array of assembly processes
- Broad array of packaging formats including rigid and semi-flexible packaging, pouches, mounting cards, and gas flushing
- Label design
- Dual sourcing and nearshoring
- Raw material and finished good inventory management
Learn more about medical device packaging, validation, and design by reading a few of the most common questions we hear from our customers.
Do orthopedic implants need to be double packaged?
How long does a package design and validation take from start to finish?
Package Design (Phase 1): 13 Weeks
- Package System Requirements
- Sterile Barrier Design
- Protective Package Design
- Verification Testing
- Sterile Presentation Test
Sealing and Manufacturing Process Development (Phase 2 - 3): 16 Weeks
- Thermoforming & Sealing Tooling
- Thermoforming IQ/OQ
- Sealing IQ/OQ
- Device Assembly IQ/OQ
- Label Development
- Build OQ-Low for Transit Test
Transit Testing and Seal Testing (Phase 4 - 6): 13 Weeks
- Expose to Worst-Case Sterilization
- Transit Simulation
- Accelerated Aging Testing
- Real-Time Aging Testing
- Seal Integrity Test
- Seal Strength Test
- Product Stability Test
- Seal Testing
- Accelerated Aging
- Real-Time Aging
- Seal Integrity Test
- Seal Strength Test
Sterilization Validation: 8 Weeks
- Manufacturing PQ
- Single Lot Verification 1
- Single Lot Verification 2/3 (Additional 16 Weeks)
These are typical lead times, but they can be significantly reduced by selecting an outsourcing partner well versed in all aspects of the process as well as having vertically integrated packaging and manufacturing processes.
Should the packaging performance qualification (distribution simulation) be done at the same time as the stability study?
No. ISO 11607-1 Section 6.4.4 indicates that stability testing and performance testing are separate entities.
Stability testing is testing the sterile barrier system. The stability test will demonstrate the shelf life of the sterile barrier irrespective of what is inside the package.
Performance testing is testing how the packaging system responds to shipping and handling stresses. The performance test must demonstrate that expected shipping stresses do not compromise the sterile barrier.
Let’s Get Started.
A conversation with J-Pac is your first step to having a manufacturing partner you can count on.