Medical Device Standard ISO 13485

ISO 13485 specifies requirements for a Quality Management System where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.


  1. ISO 13485 Overview & Implementation Training
  2. Create a Customized Quality Manual
  3. Process Owner Awareness Training
  4. Create the QMS Processes & Procedures
  5. Employee Awareness Training
  6. Implement & Generate Conformance Records
  7. Internal Audit & Management Review
  8. Stage 1 & Stage 2 Registrar Audit

McDae's team is here to make your implementation simple, smooth, and seamless. Our team takes the guesswork out of the certification process and reduces the stress on your internal resources. Our job is to make your job easier and to ensure your ISO 13485 Quality Management System adds value not burden to your company. 

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Examples of ISO 13485 Elements

  • Document & Record Control
  • Assigning a Management Representative
  • Establishing Communication Processes
  • Controlling Infrastructure & Maintenance 
  • Contamination Control
  • Criteria to Select & Approve New Suppliers
  • Criteria to Evaluate the Performance of Existing Suppliers
  • Purchasing & Receiving 
  • Product Cleanliness
  • Sterile Medical Devices & Sterile Barrier Systems
  • Controlling Implantable Medical Devices 
  • Reporting to Regulatory Authorities
  • Preventive Action
  • Maintaining Medical Device Files
  • Maintaining a Quality Policy & Objectives
  • Internal Audits & Management Reviews
  • Determining Product & Customer Requirements
  • Reviewing Product & Customer Requirements
  • Controlling Design and Development
  • Maintaining Design & Development Files
  • Production, Inspection, and Calibration
  • Installation & Servicing Activities
  • Validation of Special Processes
  • Customer Feedback & Complaint Handling
  • Control of Nonconforming Product
  • Corrective Action