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
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
Medical Device Assembly & Packaging Products
Our capabilities apply to a broad spectrum of consumable, single-use medical devices comprised of multiple plastic and metal components, assembled, tested, packaged, and sterilized.
Learn more about medical device packaging, validation, and design by reading a few of the most common questions we hear from our customers.
How does J-Pac perform a cleaning validation?
J-Pac uses approved protocols for all validations, including cleaning. The medical device cleaning validation is designed to show that contaminants that come in contact with the product during manufacturing and packaging are safely removed. These contaminants include organic residues (such as oil), inorganic residues (such as leftover particulates from processing), and microbiological contaminants (such as bioburden from inadequate operator hygiene controls).
The key components of the validation are:
- Process FMEA to determine possible sources of contaminants, including suppliers that touch the device
- Benchmarking non-cleaned parts
- Establishing acceptance criteria
- Grouping of samples by material type/family, cleaning process
- Identification of worst-case conditions to test
- Establishing a statistically rationale sample size
- Establishing the cleaning process steps and parameters
- Post cleaning testing
- Establishing Alert and Action Levels
- Establishing post validation sampling plan and change control plan
How do I determine sample size?
Should the medical device packaging performance qualification (distribution simulation) be done at the same time as the product stability study?
No. ISO 11607-1 Section 6.4.4 indicates that stability testing and performance testing are separate entities.
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.