Accumedix Services

By: Accumedix  09-12-2011
Keywords: Packaging, Iso, Medical Device

Medical Device Contract Manufacturing

Accumedix Services

Accumedix offers a comprehensive range of services to support medical device manufacturing services: 

  • Turnkey quality, manufacturing, packaging and distribution services
  • Start-to-Finish medical device commercialization: Obtaining regulatory approvals; regulatory facility registrations and device listings; design control processes, component and raw material procurement, start-up and ongoing production and process control; receiving, in-process and final inspections; drop shipping direct to the end user
  • Documented quality system compliant to ISO 9001, ISO 13485, Medical Device Directive and FDA Quality System Reg, 21 CFR Part 820
  • Contract assembly and packaging
  • Product and design control, prototyping, process development, clinical trial production, validation protocol development, testing and reports
  • Vendor approval, sourcing and procurement, receiving and inspection, component stocking with full lot control
  • Assembly, testing and packaging in clean room or non-clean room environments with lot control, in-process and final quality assurance
  • Coordination of sterilization and laboratory testing through ISO certified facilities
  • Project management and oversight to ensure all requirements for a successful project are fulfilled.
  • Environmentally controlled manufacturing including 600 square foot clean room
  • Quality controlled warehousing
  • Quality management representation
  • Regulatory and Quality consulting services

Keywords: contract manufacturing, Iso, Medical Device, Medical Device Contract Manufacturing, Packaging,