With a transition time ISO 13485:2016 started to apply on 1 August 2016. Thus, manufacturers of medical devices had to change their quality management system accordingly until 31 March 2019. Like MDR/IVDR ISO 13485:2016 especially introduces the risk based approach (4.1.2) into quality management. This version of ISO 13485 required adaptation in the following areas:

• Risk management: now required in all areas of quality management (4.1.2)
• Outsourced processes: explicitly included in QM system (4.1.5)
• Software validation: required for each software used in the QM system (4.1.6)
• Medical device file (4.2.3): corresponds with "Device Master Record (DMR)" (US 21 CFR Part 820.181)
• Human ressources: Proof of expertise of co-workers responsible for product quality (6.2)
• Sterile medical devices: contamination control + documentation (6.4.2)
• Product realization: transfer from development to production incl. documentation defined in more detail (7.3.8)
• Design and development file (7.3.10): corresponds with "Design History File (DHF)" (US 21 CFR Part 820.30(j))
• Complaints: procedure defined (8.2.2)
• Regulatory Authorities: Procedure for reporting + documentation has to be defined (8.2.3)
• Non-conforming products: handling defined in detail (8.3)
• Medical device family (3.12): introduction allows combination e.g. of single device usability analysis.