Comprehensive Regulatory Data Management
Centralized EU MDR and EU IVDR compliance data management system
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.
Centralized EU MDR and EU IVDR compliance data management system
Simplified creation, review, and approval of documentation necessary for product registration and conformity assessments.
Access Acquis' expertise in EU regulations to interpret requirements and optimize compliance strategies tailored to your organization's needs.
Automated tools to track regulatory changes and ensure ongoing compliance with EU EU MDR and EU IVDR regulations.
Organized records and documentation for compliance audits
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.
6705 Ridgedale CT, Glen Allen, VA 23059
+1.757.801.2760
info@aquiscompliance.com
#9/2, Hennur Bagalur Main Road, Bengaluru - 560077
+91 789 238 1827
info@aquiscompliance.com