eQMS Software for MedTech & Medical Device Quality Management
Icologiq Elements is an EQMS (Enterprise Quality Management System) that allows companies to create a safe, organized, and controlled framework where multiple departments can access precise information and collaborate efficiently in quality-related activities to meet compliance requirements even in the most regulated industries.
Discover how Icologiq Elements solves
industry-specific problems
What matters in MedTech & Medical Device Quality Management
Regulatory compliance & document control
Medical device Quality Management requires controlled documentation and evidence to support requirements such as ISO 13485, the EU MDR and IVDR, and applicable FDA Quality Management System requirements. Teams need confidence that procedures, records and approvals remain current and traceable.
CAPA, change & quality control
Non-conformities, corrective and preventive actions, product or process changes and audit findings need structured workflows, clear ownership and documented follow-up. Connecting these processes helps Quality teams maintain control as products and organizations evolve.
Traceability, risk & post-market quality
Quality teams need fast access to complaints, product information, procedures and related records when investigating risks or potential product issues. A connected eQMS supports traceability from issue identification through investigation, action and follow-up.
Built for Quality teams in regulated MedTech & Medical Device environments
Icologiq's specialized team supports each client to configure our standard solutions for their specific use cases, business structure, and locations, which allows our consultants to have relevant knowledge on industry-specific insights at global level.
Icologiq Elements supports connected Quality Management processes for MedTech and Medical Device organizations, including:
Managing controlled documents, procedures and approvals.
Structuring non-conformity, CAPA and complaint workflows.
Controlling product, process and documentation changes.
Planning audits and managing findings and follow-up actions.
Supporting supplier and vendor quality processes.
Connecting risk-related information with Quality processes.
Managing competence and training requirements across teams and locations.
