The FDA recently held a panel meeting regarding Eto Sterilization. Topics included replacement sterilization methods, reduction in EtO usage, impact of shortages, and reduced SAL requirements. J-Pac is currently adding in-house EtO capacity to help our customers, especially early stage customers, cope with the capacity reduction experienced in the industry. Learn more at https://lnkd.in/fVri6ja
This white paper is meant to identify critical considerations related to WIP Exposure vulnerabilities of resorbable polymers. A structured and disciplined assessment of the different contributors to the Overall Exposure Risk will enable a fact based decision pathway that will result in the establishment of a repeatable and capable manufacturing, packaging and sterilization processes that […]
Provides a validated QMS solution to accommodate increased regulatory requirements Somersworth, NH (October 11, 2019) – J-Pac Medical, a leading medical device outsourcing partner announced that it has adopted an electronic Quality Management System that seamlessly integrates all of its quality and regulatory compliance processes. The suite of validated, FDA/ISO compliant electronic business processes is […]
Additional Cleanroom Capacity is Due to Market Demand and Growth J-Pac Medical, a leading manufacturing and packaging outsourcing partner to medical companies, has opened a new manufacturing facility in Cartago, Costa Rica. The new facility houses a Class 8 cleanroom and adds capacity for J-Pac to manufacture and package medical devices that require stringent environmental […]
MPO Summit 2019 10/3/19-10/4/19 Silicon Valley, CA J-Pac Medical, the leading manufacturing and packaging outsourcing partner to medical companies, is sponsoring and attending the 2019 MPO Summit. This event, occurring October 3-4 at Marriott San Francisco Waterfront Hotel, will bring together experts from industry OEMs, contract manufacturers, suppliers, consultants, members of the investment community, and academia.
Here’s an explanation of how to coordinate all of the validation requirements to get single-use medical devices to market faster and less expensively.
Multiple factors are impacting the closing, but critical, processes associated with the end of product manufacturing.
J-Pac Medical, a leading manufacturing and packaging outsourcing partner, has added unique 3D printing capability to assist medical device and diagnostic companies further. This manufacturing technology enables J-Pac to produce end-use strong, functional prototypes of medical device components within hours.
J-Pac Medical adds absorbable polymers to capabilities.
J-Pac Medical, a manufacturing and packaging outsourcing partner to medical device and diagnostics companies, showcases materials expertise at MD&M East.