Transition to IVDR with EQMS

Implementing a robust EQMS will help automate the transition from EUDAMED and related processes

On May 26, 2022, In Vitro Diagnostic Directive (IVDD) will be replaced by In Vitro Diagnostic Medical Device Regulation (IVDR), introducing a new approach to how in vitro diagnostic devices (IVDs) will be regulated in the European Union (EU). In Vitro Diagnostic Medical Device Regulation (IVDR) replaces the previous IVD directives to enable reliable and effective IVDs. The amended directives include regulatory changes and requirements to enhance the safety and efficacy of IVDs for non-EU manufacturers and economic operators with commercial operations in the European Economic Area (EEA).

Article 10 of IVDR mandates a quality management system to ensure that manufacturing, change control, customer complaints, resource management, supplier and subcontractor controls and validation, performance evaluation, quality test, UDI labeling, post-market surveillance, etc. are according to the approved QMS and Post-Market Surveillance (PMS) plans. Implementing a pre-validated Enterprise Quality Management System (EQMS) will undoubtedly make life easier for quality leaders who are gearing up to meet the stringent and complex requirements of IVDR.

A six-step approach to meet IVDR using EQMS

Improved Products and Business

Innovate with an adaptable quality platform
Drive continuous improvement and business growth
Deliver exceptional customer experiences to build customer loyalty
Leverage your data for a factual approach to decision making
Gain greater efficiency by getting things right the first time

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Consistency

Reduce variability of materials, waste, and rework to cut time and costs
Keep quality processes repeatable to increase knowledgeable staff and reduce human error
Prevent delays by minimizing disruptions to stay on time and under budget
Improve process control to minimize quality gaps
Reduce lead time and increase production yield

Effective Compliance

Ensure quality standards are being met

Experience total traceability

Turn insights into action

Provide historical audit trails to speed compliance

Become adaptable to changing or emerging market conditions and to environmental and other government regulations.

Powerful, complete EQMS

We conducted a thorough, comparative review of systems within our budget and CQ was a clear winner. The system is powerful and versatile, even with an out of box implementation. The functionality is complete, covering every significant aspect of a quality system. Validation is straightforward with the use of OQ scripts from CQ, which can be modified to fit your implementation. It ensures that processes implemented through the system and records generated by the system are compliant for medical device companies. But, the biggest benefit we’ve received is through the collaborative partnership with CQ personnel. They listen and understand our needs. They are creative in helping us make implementation as easy as possible. Having been in large companies and small, I can see this system fitting in either environment and budget.