• Eleven Class 7 and 8 clean rooms, including a Class 7 dry room
  • Certified bi-annually to ISO 13485. Monthly non-viable testing; daily differential pressure monitoring; and quarterly viable testing is performed
  • ISO 13485-Compliant Quality System
  • ERP system with lot traceability to suppliers’ raw material lot numbers
  • Controlled labeling process and dedicated, secure room
  • Lot release, including parametric sterilization release when applicable
  • Calibration program
  • Validated manufacturing processes


At J-Pac Medical, our commitment to quality is uncompromising. With effective quality systems and stringent quality measures in place, J-Pac Medical has cultivated an environment of responsibility and empowerment in which every member of our team has ownership of the quality control process and follows strict accountability guidelines at every step. Quality is continually assessed through internal monitoring as well as stringent audits conducted by customers and independent auditors. J-Pac Medical has implemented an ERP System to ensure precise inventory control, production scheduling, quality control, and financial reporting. J-Pac Medical is FDA Registered (#1221051) as a Medical Device Manufacturer and a Device Labeller/Relabeller.

J-Pac Medical is certified to ISO 13485 standards through BSI.  To meet the requirements for ISO Certification, J-Pac Medical demonstrated its implementation of a Quality Management System for the contract manufacturing of thermoformed plastics and the contract assembly and packaging of medical devices that consistently meet customer and regulatory requirements.