Streamline quality operations, accelerate product release, and maintain compliance with FDA, MDR, and ISO 13485 using a validated QMS for Medical Device manufacturers.
Streamline quality operations, accelerate product release, and maintain compliance with FDA, MDR, and ISO 13485 using a validated QMS for Medical Device manufacturers.
Medical device companies face intense regulatory oversight, where fragmented systems and manual workflows increase the risk of delays, recalls, and findings. Quality Forward simplifies quality operations by centralizing critical processes and ensuring full traceability.
Verify and monitor supplier quality, certifications, and material compliance. Digitally manage audits, onboarding, and risk-based qualification.
Implement ISO 14971-aligned frameworks to identify, assess, and reduce product and process risks. Integrate risk controls across the design lifecycle.
Ensure every employee is trained, qualified, and audit-ready. Automate training assignments linked to SOP updates and role changes.
Manage internal and external audits from planning to response. Maintain complete, inspection-ready audit records.
Log and track adverse events and nonconformities with clear escalation paths. Automate reporting and resolution workflows.
Centralized complaint intake, investigation, and trending. Ensure compliance with post-market surveillance and vigilance reporting.
Control all quality documents, including DHFs, DMRs, SOPs, and validation files. Comply with FDA 21 CFR Part 11 and ISO 13485.
Structure engineering and quality changes across design, manufacturing, and suppliers. Ensure cross-functional impact assessments and approvals.
Trigger CAPAs from audits, complaints, or deviations. Track effectiveness and link directly to risk and regulatory standards.
Capture shop floor deviations and NCRs in real time. Investigate, assess impact, and implement corrective actions efficiently.
Medical device manufacturing demands traceability, design control, and audit readiness at every stage. This is where Quality Forward helps unify complaints, deviations, CAPAs, document control, and change management in a validated platform – purpose-built for FDA QSR and ISO 13485 compliance.
Streamline quality events, reduce release delays, and maintain inspection readiness with connected workflows and real-time visibility across operations; all powered by the trusted Now Platform.
Adapt fast to procedure changes without developer support-ideal for dynamic regulatory environments.
Achieve full QMS digitalization without the high cost of custom solutions. Scale confidently from one site to global operations.
Used by device manufacturers across Class I–III, and diagnostics to ensure inspection readiness and regulatory alignment.
Connects with PLM, ERP, MES, and CRM systems to ensure data consistency and reduce manual entry risk.
Proactively identify and address recurring issues in complaints, CAPAs, and supplier quality using predictive dashboards.
Secure, validated, and ready for enterprise deployment on the ServiceNow platform.
