Research objectives and hypothesis/research questions:
The review is guided by three primary research questions: RQ1: Which QMS practices (e.g., ISO 13485 documentation, internal/external auditing, risk management, PMS/quality-data activities) are most frequently studied in MedTech organizations, and how are they operationalized? RQ2: Which outcome categories dominate (e.g., compliance/market access, time-to-market, cost of quality, innovation, operational performance, competitive outcomes), and how are they measured? RQ3: Which research designs and methods are most common, and what theoretical and methodological gaps remain for operations and quality management research?

Research methods:
Searches were conducted in Web of Science Core Collection and Scopus (time window 2020–2026; peer-reviewed journal articles and conference papers; English). Following PRISMA 2020 procedures (identification, screening, full-text eligibility), 60 records were identified (50 Web of Science; 10 Scopus). After title/abstract screening and full-text retrieval, 13 studies met inclusion criteria from the database search. Forward and backward snowballing of reference lists and citations of included studies identified one additional eligible study (Linck, Tinoco, Bonato et al., 2025). In total, 14 studies were included. Data were extracted using a structured coding frame (context, QMS domain, operationalisation, outcomes, method, key findings). Study quality was appraised using MMAT 2018, where applicable, acknowledging heterogeneity in design.

Main results:
Evidence concentrates on four practice clusters: (1) QMS documentation, certification, and maturity assessment, (2) auditing and audit-readiness as governance of compliance and translation, (3) risk management (including cybersecurity and SME constraints), and (4) quality data and post-market surveillance (including AI-enabled literature surveillance and malfunction reporting barriers). Competitive outcomes are typically proxied rather than measured directly, most often via compliance capability, recall risk mitigation, innovation constraints under regulatory change, and operational efficiency. Quantitative, multi-firm evidence linking specific QMS practices to product competitive advantage remains rare.

Implications for theory and practice:
The review consolidates fragmented streams (regulatory, clinical governance, AI-enabled surveillance, SME risk management, QMS maturity assessment) into an integrated capability model: QMS practices enable regulatory market access, organisational learning, and operational reliability, which in turn shape time-to-market, cost of quality, and innovation performance. A research agenda is proposed with testable hypotheses and measurement pathways aligned with operations management standards.