SAI Global partners with medical device companies on highly-configurable compliance and risk management solutions.
The medical devices industry sector is one of fast-moving technological advancement. To compete successfully, you have to ensure you’re meeting the complex regulatory and reporting requirements governing medical devices safety, quality, manufacturing, sales and marketing. This includes cross-industry regulations and mandates such as Sarbanes Oxley and the FCPA as well as industry specific laws and standards such as the AdvaMed Voluntary Code of Ethics on Interactions with Healthcare Professionals.
And because global businesses manage culturally diverse workforces, hundreds if not thousands of suppliers and business partners, there are the added challenges of effective communication, documentation, and consistency.
SAI Global provides the medical device industry’s most comprehensive and practical solution to its compliance and risk management challenges. SAI Global not only provides the core elements of compliance but also aggregates the raw data of compliance - such as survey responses, hotline reports, incidents, training completion rates, regulatory content, risk assessment profiles, and policies - so that
compliance and risk management professionals can see and take action on the emerging risks and trends in their GRC programs.
Our GRC solution for the medical device industry includes:
- More than 150 Best Practices Code of Conduct segments you can configure to communicate an Employee Code of Conduct and/or a Supplier Code of Conduct
- The industry's most complete and dynamic library of courses that communicate regulations and mandates such as Sarbanes-Oxley, FCPA, Global Anti-Bribery, conflicts of interest, gifts & hospitality, data privacy and many others
- Training on national and international standards such as ISO9001 and ISO27002
- A powerful solution to enable a continual audit-ready state - the Compliance 360® Virtual Evidence Room® dynamically links all policies, surveys, assessments, attestations, incidents, audits, contracts, projects and tasks directly to laws, regulations, standards and guidelines
- Compliance 360® Incident Management to store and collaborate on all incidents, track progress of investigations, and compile proof of remediation - and link to your hotline
- Multiple options to manage policies and procedures - core business processes for compliance and audit professionals worldwide
- Our GRC Dashboarding, designed for reporting and analysis and a welcome change from spreadsheet overload
to discuss your specific requirements or to arrange an online demonstration of any of our products or solutions.
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