Establishment of MDR-Compliant Quality Management System
We assist in establishing a Quality Management System (QMS) that fully complies with the requirements of the MDR regulation.
Establishment of Full Lifecycle Risk Management System
We establish a full lifecycle risk management system in accordance with ISO 14971:2019 and MDR regulatory requirements, including risk management plans, risk analysis/risk assessment/risk control, evaluation of residual risk acceptability and risk management reports.
Internal System Audit, Management Review & Mock Audit
Internal System Audit, Management Review & Mock Audit
Audit Support
On-site Audit Support for Notified Body QMS Audits
