Medical Devices - ISO 13485 2018

Topics

• What to Look for and where to prepare to enable one`s Organization and Personnel to Assist in an Audit for Certification
• The standard and the different Areas needed to Create, Maintain, and Sustain a proper documentation system to ensure Certification
• Supplier Demands
• Clean Rooms
• Annual upkeep
• Quality from when Materials are Received, Until after the devices leaves the Facility
• Management Representation and Participation

Who should Attend

• EH&S Reps
• Quality Managers
• QCQA
• Quality Control
• Sales
• CEOs
• Vendors etc
• Buyers