Outsourced Medical Device Assembly & Packaging Services

Turnkey Medical Device Outsourcing

J-Pac Medical is the leader in medical device assembly and contract packaging and sterilization of disposable sterile medical devices. Our outsourced medical device manufacturing and sterilization services are ideal for 3D, multi-component products.

We provide industry-leading medical device assembly and packaging services, including:

  • Sterile medical device packaging design and validation
  • Sterile medical device contract packaging
  • Sterile medical device cleanroom assembly
  • Tooling design and fabrication
  • Packaging assembly process development and validation
  • Cleanroom thermoforming
  • Medical device contract packaging
  • Manual and automated assembly
  • Medical device supply chain management
  • Secondary medical device packaging flows, including GS-1 labeling
  • Medical device packaging sterilization process validation and routine processing

Package Design

Today’s FDA and ISO regulations require dozens of separate protocols and test reports to validate that a package protects its device and stays sterile from factory, storage, distribution, and aseptic transfer to the end-user. The regulations are complex and often lead to compliance issues, recalls, and, in the worst cases, patient harm.

J-Pac’s package design and validation services include:

Smart design
Smart design starts with understanding what package formats achieve the necessary levels of cleanliness and sterility. We balance protection, ease of use, and material costs.

Virtual package photos
We will provide you with a photorealistic rendering that is indistinguishable from the real thing and much quicker.

Rapid prototyping
J-Pac uses rapid prototyping processes and quick change thermoforming equipment.

Usability feedback
Our sterile field experts will ensure that the contents of the package can be aseptically transferred into the sterile field, meeting ISO 11607 and FDA regulations.

Carton design
We minimizing material and transportation costs while assuring your entire packaging system, including carton, maintain sterility during distribution and storage to meet ISO 11607 regulations.

DHR ready validation protocols and reports
We provide you with all the unique protocols and reports of your packaging validation for your technical and regulatory files.

Simulated distribution testing
We save you time, money, and headaches by working closely with accredited testing labs for final testing. We conduct internal feasibility tests prior to conducting a simulated distribution study to ensure the package passes the test the first time.

Shelf life stability studies
We will design and execute studies that meet the ISO guidelines for stability and shelf life in the fastest possible time.

Validation

Before developing the assembly process, we conduct a DFM review of the product to determine the most efficient way to assemble it. The assembly process is then developed according to the commercialization requirements of the customer.

Assembly and packaging processes are validated based on the established critical specifications. Assembly processes undergo a formal process including Installation Qualification, Operational Qualification, and Performance Qualification. Our Performance Qualification process involves running multiple separate lots over multiple production operators, shifts, and raw material lots to ensure all processes are capable.

Production

A new program is transitioned into manufacturing using a formal process that includes a team of representatives from Quality, Manufacturing, Engineering, and Purchasing. The team follows strict guidelines to ensure all the documentation, routers, procedures, and validations are successfully completed prior to transition.

Assembly and packaging production is conducted using Lean Manufacturing processes that ensure efficiency, quality, and accountability. Small teams of trained employees with an accountable group leader ensure the manufacturing processes are followed.

Sterilization

J-Pac helps your business be successful by matching the right sterilization partner with your specific needs. We work with you to determine the factors that best fit your current needs as well as future growth.

Considerations we take into account when selecting the right sterilization company for a project:

Sterilization Method
We work with 3rd party consultants that are experts in the field to help you determine the appropriate sterilization method for your device.

Location
Sometimes the selection of the sterilizer can be sensitive to location due to the number of loads required and transportation costs.

Lead-time
Since we work with many customers and products, we have keen insight into which sterilization supplier can meet your lead-time requirements.

Chamber Equivalency
J-Pac can recommend sterilization companies that can provide the appropriate amount of chamber equivalency.

Cost
We can provide guidance to best balance your budget with capabilities.

Quality Control
J-Pac performs sterilizer supplier audits so you don’t have to.

Some sterilization companies are a better fit for your needs than others. J-Pac can help you navigate this important part of your process.

Supply Chain Management

J-Pac believes that excellent supply chain management is more than just coordinating raw materials suppliers. We will assure your product meets all regulatory requirements and provide the right mix of compliant processes, quality, and reliable availability.

We give you resources
By having J-Pac manage your supply chain, you get the benefit of our purchasing, engineering, quality, and management resources.

We sweat the details
We will purchase raw materials on your behalf. We audit suppliers through our ISO 13485:2016 compliant procedures. We track your specialized tooling and molds and coordinate with you when changes are needed. We handle the day-to-day issues so you don’t have to.

You become more nimble
When J-Pac manages your supply chain, you become more agile and can modify production requirements much easier than you can with in-house manufacturing.

We minimize risk
We manage variables that could cause compliance and delivery issues.

We respond
J-Pac is large enough to meet your needs but small enough to respond lightning fast.

We know which suppliers are best for your product
When we handle supply chain management, you only deal with us as a single supplier, yet we have the flexibility to use multiple suppliers that are best for your product.

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603.692.9955

info@j-pacmedical.com