Navigate EU MDR & IVDR Compliance With Confidence

At Acquis, we simplify compliance with the EU Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (IVDR). Whether you're a medical device manufacturer or medical equipment supplier, our solution ensures compliance with evolving warning label requirements for Section 10.4.1 substances while protecting consumer safety and maintaining market access.

PRICING

Efficiently Handle EU MDR and EU IVDR Compliance with Acquis Software and Services

Comprehensive Regulatory Data Management

Comprehensive Regulatory Data Management

Centralized EU MDR and EU IVDR compliance data management system

Streamlined Documentation Management

Streamlined Documentation Management

Simplified creation, review, and approval of documentation necessary for product registration and conformity assessments.

Expert Guidance and Support

Expert Guidance and Support

Access Acquis' expertise in EU regulations to interpret requirements and optimize compliance strategies tailored to your organization's needs.

Automated Compliance Tracking

Automated Compliance Tracking

Automated tools to track regulatory changes and ensure ongoing compliance with EU EU MDR and EU IVDR regulations.

Audit Readiness

Audit Readiness

Organized records and documentation for compliance audits

Why Choose Acquis for EU MDR & IVDR Compliance?

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01 Our platform is designed to help medical device companies efficiently manage EU MDR requirements, from device classification to regulatory updates.
02 Automate tracking of hazard chemical lists, streamline EU MDR labeling requirements and ensure audit-ready documentation for medical device supply chain management.
03 Leverage our experience in MDR regulation to navigate challenges like Section 10.4.1 compliance and identify solutions for medical device design and production.
04 Save up to 40% of time spent on compliance processes. Mitigate risks of penalties and product recalls. Maintain your market access and build consumer trust.

Features of Acquis' EU MDR & IVDR Compliance Solution

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Comprehensive EU MDR Data Management

Centralized system for medical device manufacturers to track compliance data, from device classification to new MDR regulations.

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Automated Documentation and Reporting

Simplify the creation and submission of compliance reports, ensuring adherence to EU MDR medical device classification requirements.

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Proactive Hazard Tracking

Get automated alerts for changes to the EU MDR hazard chemical list, ensuring your products meet the latest regulatory compliance medical devices standards.

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Seamless Audit Preparation

Organized documentation for inspections, reducing the burden on medical device companies and ensuring compliance with EU medical device regulation 2017.

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Determining Warning Label Requirements and Consumer Notifications

Identify and establish the necessary warning labels and notifications for consumer information compliance.

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Red Flag Alerts for Substances of Concern

Utilize red flag alerts to identify and manage chemical hazards within your products, focusing on substances requiring special attention.

Ready to Navigate EU MDR & EU IVDR Compliance and Protect Consumer Safety?

From medical device compliance software to expert consulting, Acquis is your partner for EU MDR compliance. With automation, expert guidance, and a proven track record, we enable you to focus on innovation while we handle the complexities of MDR medical device regulation.

EU MDR Compliance FAQs

What is EU MDR?

What is the EU IVDR?

Who needs to comply with EU MDR?

What are the key differences between the EU MDR and the EU IVDR?

How can Acquis Compliance software help with EU MDR compliance?

What are the consequences of non-compliance with the EU MDR or EU IVDR?\n

How can I get started with Acquis Compliance?

How can I ensure that my medical devices are compliant with the EU MDR or EU IVDR?