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
Centralized system for medical device manufacturers to track compliance data, from device classification to new MDR regulations.
Simplify the creation and submission of compliance reports, ensuring adherence to EU MDR medical device classification requirements.
Get automated alerts for changes to the EU MDR hazard chemical list, ensuring your products meet the latest regulatory compliance medical devices standards.
Organized documentation for inspections, reducing the burden on medical device companies and ensuring compliance with EU medical device regulation 2017.
Identify and establish the necessary warning labels and notifications for consumer information compliance.
Utilize red flag alerts to identify and manage chemical hazards within your products, focusing on substances requiring special attention.
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.
