Quality Management Systems

Quality Management Systems (QMS) are a worldwide requirement for marketing healthcare products and technologies. Often companies new to the healthcare arena do not have a certified QA manager on staff to implement and manage an ISO-certified system. To assist companies in meeting this requirement, CSSi LifeSciences™ offers a Company Specific ISO 13485/21 CFR 820 Quality System, which can be hosted by CSSi or the client’s company. Our fully compliant, cost efficient and custom QMS includes:

  • Standard operating procedures(SOP) and training
  • Third party certification audits
  • Partner and vendor audits
  • Design master file, technical files and eData storage
  • Dedicated ISO 13485/ 21 CFR 820 QA/QS QA manager
  • Installing the ISO quality system and all related documents and technical files on-site at the Company
  • Managing the customer dedicated service phone line and safety email system
  • CAPA (Corrective Action and Preventive Action) services
CSSi LifeSciencs™ team member talking on the phone with a client