Empowering Manufacturers, Importers, and Authorized Representatives to Navigate Global Regulations with Ease

Boston, Massachusetts, USA – February 14, 2025 –ArisGlobal , an innovative technology company at the forefront of life sciences and creator of LifeSphere® , today announced that its Next Generation & Unified MultiVigilance case management platform supports global Safety requirements for medical devices, automating and streamlining compliance with evolving global regulatory requirements. Designed to reduce manual effort and enhance data accuracy, MultiVigilance is transforming how medical device manufacturers, importers, authorized representatives, and partners manage safety vigilance and incident reporting. 

Key features of MultiVigilance include: 

• Global Compliance: More efficiently manage complexities associated with medical device requirements, including full compliance with EU MDR and IVDR regulations and support for electronic submissions to the FDA and Japan’s PMDA.  

• Automated Reporting: Reduce manual work and improve efficiency and accuracy with automated clinical investigation and adverse event reporting for medical devices. 

• LATAM Vigilance: Our solution is tailored to meet regulatory requirements across Latin America, ensuring comprehensive compliance in the region. 

• Proactive Safety Management: Built-in trend analysis tools help to quickly identify and address incident patterns. 

• Seamless Integration: Integrates effortlessly with existing Quality Complaints systems for unified data flow and streamlined operations. 

• Complex Product Support: Support the processing of complex combination products and multi-constituent devices with robust reporting capabilities. 

• Standardized Data: Automate adverse event coding using IMDRF and MedDRA mapping, ensuring consistency and reducing manual input.

Global Impact and Innovation 

MultiVigilance stands at the forefront of innovation, empowering companies to navigate the increasingly complex landscape of global medical device regulations. By integrating powerful automation, seamless system connectivity, and region-specific compliance capabilities, MultiVigilance provides a one-stop solution for companies in need of streamlined pharmacovigilance operations. The platform’s ability to automate compliance reporting, reduce manual data entry, and enhance adverse event reporting accuracy significantly benefits regulatory adherence and supports patient safety. 

“Our mission at ArisGlobal is to simplify Safety compliance, allowing manufacturers to meet the demands of global regulations without excessive manual burden,” said Ann-Marie Orange, CIO and Global Head of R&D at ArisGlobal. “We are committed to providing our clients with the tools they need to achieve greater efficiency and accuracy in maintaining compliance across multiple regions and product types, ensuring they stay ahead in a fast-evolving regulatory environment.” 

About ArisGlobal

ArisGlobal, an innovative life sciences technology company and creator of LifeSphere®, is transforming how today’s most successful life sciences companies develop breakthroughs and bring new products to market. Headquartered in the United States, ArisGlobal has regional offices in Europe, India, Japan, and China. For more updates, follow ArisGlobal on LinkedIn. www.arisglobal.com.