Our team brings extensive expertise manufacturing class ll, sterile barrier, single-use medical devices for early-stage startups through many of the world’s leading medical device companies. We do this through:

• • Quality Management System (QMS): Utilization of an internal QMS ensures that all processes meet stringent regulatory requirements.
  • Customer Collaboration: Working directly with customer-provided Bill of Materials, component drawings, and performance specifications to create controlled documented assembly protocols and work instructions.
  • Sterile Manufacturing Capabilities: Devices are assembled in a certified Class 7 clean room and packaged in sterile barrier packaging.
  • Sterilization Management: Offering management of Ebeam, Gamma, or EtO sterilization through validated service providers.
  • Certifications: FDA registration and ISO 13485:2016 certification, underscoring a commitment to quality and regulatory compliance.