Webinar: CAPA Under Scrutiny: What FDA Inspectors Really Look For in 2026

Discover your potential savings with our ROI Calculator

Calculate ROI now

Transition to IVDR with EQMS

transition to ivdr with eqms

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

transition to ivdr with eqms

transition to ivdr with eqms video

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

six-step approach to meet IVDR

IVDR - improved products and business

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

Request an Online Demo

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

IVDR - consistency

EU IVDR

Gearing up for EU IVDR

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.

IVDR - effective compliance

implementation tips for EU IVDR

Implementation Tips for EU IVDR: Evaluate your Preparedness

implementation tips for EU IVDR

Risk Reduction

Provide visibility between your quality processes, product record, requirements, issues, and related processes
Enable teams to confirm designs easily, adjust plans, and resolve issues fast
Quickly find the root cause and speed up resolution
Predictive analysis of data reduces the risk of probable quality failure
Limit damages to profits, reputation, and existing relationships

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.

Jackie Jaskula,
Director of QA and Regulatory

Managing the IVDR Transition with ComplianceQuest EQMS

For a successful outcome, manufacturers, including economic operators (Importers, Authorized Representatives, Distributors) must work closely and cooperate with the Notified Bodies, suppliers, and sub-contractors of the European Commission and Competent Authorities to ensure the legislative framework is successfully adopted, and safe products are continually available to the patients in need.

ComplianceQuest’s EQMS solution is designed to manage the entire product lifecycle right from well-established technical documentation, procedures, document management, change control, design control, CAPA, etc. This can help meet IVDR requirements more intuitively and enable automating the various quality areas, assisting auditors in evaluating the process, data quality, and integrity.

Some of the ComplianceQuest EQMS’s features that facilitate IVDR transition include:

ivdr cloud based system

Cloud-Based System

A next-generation, cloud-based EQMS like ComplianceQuest will make it easy to ensure people, processes, and systems are genuinely connected. It will help enhance productivity, streamline collaboration, and ensure seamless flow of information across the organization. ComplianceQuest’s cloud-based EQMS provides real-time data analysis and updates that play a crucial role in being 24/7 audit-ready.

digital change management

Digital Change Management

Unless QMS documentation is digitally managed, change management will be erroneous or would lack updating. ComplianceQuest Document Management Solution enables you to manage the entire document lifecycle and gain complete visibility as you transition to IVDR. With an electronic approach to document management, leaders responsible for this transition to IVDR will have a central repository to create, modify, review, approve, store, organize, access, and share documents globally in a controlled manner.

IVDR - suppliers and sub contractor controls

Suppliers and Sub-Contractor Controls

IVD manufacturers depend on various suppliers to produce and deliver safe, accurate, and effective products for human use. Thus, regulatory and quality concerns are also evolving when it comes to suppliers and subcontractors. Convey the IVDR requirements to the suppliers and ensure new agreements are in place. ComplianceQuest Supplier management solution offers supplier and sub-contractor controls and validation helps avoid the risk of IVDR noncompliance.

IVDR - post market surveillance and vigilance

Post-Market Surveillance and Vigilance

Manufacturers are required to produce the PMS Plan and Report/Periodic Safety Update Report (PSUR) following the IVDR. A procedure to perform PMS and vigilance should be in place, and it should be continuously updated. A robust and reliable quality management system (QMS) such as the one from ComplianceQuest allows users to have a post-market performance follow up plan.

internal and external communication

Internal and External Communication

Real-time communication with quantifiable data within and external to the organization is essential. Our QMS module is equipped with effortless communication channel while the system is available on mobile. This facility helps communicate the whole process to all the suppliers, sub-contractors, or service providers and their obligations.

Cloud-Based System

A next-generation, cloud-based EQMS like ComplianceQuest will make it easy to ensure people, processes, and systems are genuinely connected. It will help enhance productivity, streamline collaboration, and ensure seamless flow of information across the organization. ComplianceQuest’s cloud-based EQMS provides real-time data analysis and updates that play a crucial role in being 24/7 audit-ready.
Digital Change Management

Unless QMS documentation is digitally managed, change management will be erroneous or would lack updating. ComplianceQuest Document Management Solution enables you to manage the entire document lifecycle and gain complete visibility as you transition to IVDR. With an electronic approach to document management, leaders responsible for this transition to IVDR will have a central repository to create, modify, review, approve, store, organize, access, and share documents globally in a controlled manner.
Suppliers And Sub-Contractor Controls

IVD manufacturers depend on various suppliers to produce and deliver safe, accurate, and effective products for human use. Thus, regulatory and quality concerns are also evolving when it comes to suppliers and subcontractors. Convey the IVDR requirements to the suppliers and ensure new agreements are in place. ComplianceQuest Supplier management solution offers supplier and sub-contractor controls and validation helps avoid the risk of IVDR noncompliance.
Post-Market Surveillance And Vigilance

Manufacturers are required to produce the PMS Plan and Report/Periodic Safety Update Report (PSUR) following the IVDR. A procedure to perform PMS and vigilance should be in place, and it should be continuously updated. A robust and reliable quality management system (QMS) such as the one from ComplianceQuest allows users to have a post-market performance follow up plan.
Internal And External Communication

Real-time communication with quantifiable data within and external to the organization is essential. Our QMS module is equipped with effortless communication channel while the system is available on mobile. This facility helps communicate the whole process to all the suppliers, sub-contractors, or service providers and their obligations.

Meet IVDR regulation using the EQMS solution to manage the entire product life cycle

Request an Online Demo

Quality-centric Companies Rely on CQ QMS

Mascot Astronut

Related Insights

AI in Supplier Management: What Works and What’s Hype

Blog | August 21st, 2026

AI in Supplier Management: What Works and What’s Hype

A few years ago, we published a blog on Task Automation & Better Decision Support with ComplianceQuest’s AI Agents. At the…

Blog | August 20th, 2026

Why Documentation Errors Continue to Delay Medical Device Product Release

In Brief: Documentation errors are often viewed as the reason…
Whitepaper | July 29th, 2026

Executive Brief: How To Stop Losing Governance Between Management Reviews

Governance Doesn't Live in the Meeting. It Lives in What…
Blog | July 22nd, 2026

Supplier Risk is No Longer a Procurement Problem

Supplier risk is no longer confined to procurement. As supply…

View All Resources