Contract Packaging of Single-Use Surgical Kits

A Turnkey Medical Device Outsourcing Partner for Single-Use Medical Devices

Sterile Medical Device Contract Packaging

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.

In-house tooling made with CAD CAM CNC

Medical Device Assembly & Packaging Services

From package design to sterilization validation and manufacturing scale-up, J-Pac has the expertise to get you to market faster.

Cleanroom assembly using ultrasonic welding

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.

Helpful information about Medical Device assembly & packaging

White Papers

Read White Papers written by the experts in Medical Device Assembly & Packaging.

Product Sheets

Download the details you need about Medical Device Assembly & Packaging products and services from J-Pac Medical.

FAQs

Learn more about medical device packaging, validation, and design by reading a few of the most common questions we hear from our customers.

How do I determine sample size?

There is no single standard for sample size selection. When determining the right sample size for your product, the most important factor to consider is risk. ISO 11607-1 section 4.3 indicates that sample sizes must be based on some statistical rationale and references sampling plans in ISO 2859-1 and ISO 186.

What is ISO 11607?

ISO 11607 is the standard for packaging terminally sterilized medical devices and is comprised of two parts.

ISO 11607-1:2006 specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems, and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.

ISO 11607-2:2006 specifies requirements for development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing, and assembly of preformed sterile barrier systems and packaging systems.

Part 1 addresses Materials and Design while Part 2 addresses Packaging Process Validation. These are both required to satisfy the Essential Requirements of the European Directives to achieve CE Marking. Additionally, this guidance document is recognized by the FDA and used for premarket review submissions.

Is cleaning validation required for orthopedic implants?

If the orthopedic implant is cleaned prior to packaging, the cleaning process must be validated to ensure a high probability that the cleaning specifications are met (FDA CGMP). There have been numerous recalls in orthopedics caused by cleaning processed getting out of control, which left patient harming contaminants on the product. A cleaning validation should be evaluated starting with a product and process FMEA that shows possible sources of contamination and their impact and severity.
Medical Face Shields

Medical Face Shields

J-Pac Medical is the trusted partner for producing the highest quality medical face shields.

Sterilized implantable medical textile for hernia repair formed from polypropylene mesh

Medical Textiles

Custom formed and particulate-free biomedical textiles for medical devices and allograft processing

Cold formed reagent blisters mounted on a microfluidic diagnostic consumable

Diagnostic Reagent Blisters

Partner with J-Pac Medical to produce your custom diagnostic reagent blisters to speed processing and reduce errors.

Call Our Engineers Now

603.692.9955

info@j-pacmedical.com