Quality management (QM) means continuous improvement of all quality relevant processes with the goal of a consistent product quality and to improve this quality constantly. To make the respective efforts more tranparent and comprehensible for Notified Bodies and authorities they need to be documented accordingly. This documentation is required by laws and standards. It requires some more effort but it helps as well in safeguarding your company against lawsuits.

In the EC MDR/IVDR meanwhile requires a quality management system for manufacturers of non-sterile class I products as well. This system is defined in more detail in ISO 13485 which has been revised in 2016 and again adopted in 2021. In the US the quality system regulation (QSR) of 21 CFR Part 820 governs the quality management system.

Among others the quality management system comprises the following elements:

• Risk Analysis (ISO 13485:2016 "risk based approach" / US § 820.30(g)),
• Usability via verification and validation (7.3.6+7 / US § 820.30(f)+(g) as well as 7.5.1 / § 820.75),
• UDI (Unique Device Identification (7.5.8 / § 820.60)) and Traceability (7.5.9 / § 820.70),
• Post Market Surveillance (MDR), incl. complaints (8.2.2 / §820.198) and CAPAs (8.5.2+3 / §820.100),
• Biocompatibility in the context of validation and control of contamination (6.4.2 / § 820.70(e)) as well as
• Clinical Evaluation and investigation as important part of design validation (7.3.7 / § 820.30(g)).