Axway Medical Device Manufacturer Solutions

Axway solutions provide the governance, security, and community management capabilities medical device manufacturers need to protect against data loss, ensure regulatory compliance, and streamline information exchange processes throughout their business interaction networks.

Policy-based secure email and file attachment management

Axway MailGate provides outbound email encryption, data leak prevention, and complete audit trails for compliance with government regulations, industry standards, and corporate security policies. Using MailGate, medical device manufacturers can comply with government regulations; define custom lexicons to enforce corporate policies that protect intellectual property, regulatory reports, and clinical trial information; ensure the confidentiality of outbound messages by automatically applying the most appropriate encryption method for recipients; track and document compliance for regulatory and legal risk mitigation; and protect data and systems from spam, viruses, phishing, hackers, and other email threats.

Comprehensive and secure Managed File Transfer (MFT) solutions

Axway MFT solutions offer a broad spectrum of security measures to protect against data loss and improve governance. Complete audit trails simplify and lower the cost of compliance with industry and government regulations such as HIPAA, GLBA, and SOX, as well as with your organization’s internal security and privacy policies. End-to-end monitoring and tracking of file movements delivers granular visibility into your entire file transfer infrastructure — no matter what applications, systems, or platforms you or your trading partners have in place.

Global eSubmissions

Designed for medical/surgical device manufacturers, pharmaceutical companies, research organizations, and biotech companies, Axway eSubmissions integrates seamlessly into existing infrastructures to quickly and efficiently create collaborative connections that improve the efficiency and lower the costs of transmitting reports to both industry partners and regulatory authorities. Regulators around the world, including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMEA), and the Japanese Ministry of Health, Labor and Welfare (MHLW) have all standardized on Axway eSubmissions for regulatory documentation.  

eMDR

Axway eMDR provides complete management of eMDR submissions in compliance with the FDA’s eMDR mandate.