ISO 13485 Implementation Services

Whether you are just beginning your journey to certification or you are faced with aggressive timelines to meet the ISO13485 or MDR transition deadlines, RCA’s quality assurance experts can help. 

ISO 13485 Implementation Services

  • Quality System Implementation
  • Quality System Transition
  • Standard Operating Procedure (SOP) Development
  • Document Control Implementation
  • Design Controls
  • Design History File Creation
  • Risk Management (ISO14971)

Contact us

    Begin the Regulatory Compliance Associates Scoping Process Today

    Contact Us