Comprehensive Regulatory Data Management
Centralized EU MDR and EU IVDR compliance data management system
EU MDR & EU IVDR Software, Services & Consulting
Our comprehensive software, consulting, and services empower Medical Device companies to achieve compliance with the EU Medical Device Regulation (MDR) and the EU In Vitro Diagnostic Medical Device Regulation (IVDR) and help you to determine the warning label requirement for Section 10.4.1 substances. Let us be your trusted partner in managing EU MDR & EU IVDR requirements effectively and efficiently.
Efficiently Handle EU MDR and EU IVDR Compliance with Acquis Software and Services
Streamlined Documentation Management
Simplified creation, review, and approval of documentation necessary for product registration and conformity assessments.
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 tools to track regulatory changes and ensure ongoing compliance with EU EU MDR and EU IVDR regulations.
Audit Readiness
Organized records and documentation for compliance audits
Benefits of Choosing Acquis for EU MDR Compliance
01 Ensure EU MDR & IVDR compliance, reducing legal risks and protecting brand reputation.
02 Demonstrate commitment to consumer safety, boosting trust and loyalty.
03 Streamline compliance processes, optimizing resource use and operational efficiency.
04 Stay updated on regulatory changes for continuous compliance and market access.
05 Mitigate risks of penalties and litigation associated with non-compliance.
06 Receive tailored guidance on Section 10.4.1 compliance and specific regulatory requirements.
Streamline EU MDR Compliance with Acquis Software and Services
Efficient Compliance Documentation Sourcing
Efficiently procure and validate documentation to ensure adherence to regulatory requirements.
Tracking EU MDR & EU IVDR Hazard Chemical List Changes
Efficiently monitor updates and revisions to the EU MDR and EU IVDR hazard chemical list outlined in Section 10.4.1.
Streamline Compliance Documentation and Reporting
Simplified processes involved in documenting and submitting compliance reports.
Effortless Ongoing Compliance Monitoring
Manage continuous monitoring of compliance requirements with ease.
Determining Warning Label Requirements and Consumer Notifications
Identify and establish the necessary warning labels and notifications for consumer information compliance.
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?
Book a demo or contact our EU MDR & EU IVDR Compliance Experts to learn how Acquis Compliance software and services can simplify your EU MDR & EU IVDR compliance.
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?
ENVIRONMENTAL COMPLIANCE
- RoHS
- SCIP (WFD)
- REACH
- California Proposition 65
- Material Disclosure (FMD)
- PFAS
- TSCA PBT
- EU POPs
- EU MDR & IVDR
- ELV (GADSL)
- Others
- Extended Producer Responsibility (EPR)
INTEGRATION SUPPORT
WE ARE GLOBAL
USA
6705 Ridgedale CT, Glen Allen, VA 23059
+1.757.801.2760
info@aquiscompliance.com
India
#9/2, Hennur Bagalur Main Road, Bengaluru - 560077
+91 789 238 1827
info@aquiscompliance.com