PRINCETON, N.J. & WASHINGTON--(BUSINESS WIRE)-- UL EduNeering, part of UL (Underwriters Laboratories), a global independent safety science company and AdvaMed, the world’s largest medical technology trade association, announced the launch of the AdvaMed Regulatory and Compliance Certificate (ARCC) Program. This online certificate program is designed to enhance professional development for medical technology professionals and allow them to keep abreast of a rapidly changing environment. The ARCC program provides the latest information on relevant medical device issues and FDA regulations as well as practical information and skills to apply on the job.
The ARCC program, an online certificate program jointly developed between AdvaMed and UL EduNeering, offers three separate program options (tracks) and leverages UL EduNeering’s extensive online libraries, including both FDA and AdvaMed-approved content. Each track includes 3-4 required courses and 6-7 electives, which have been specifically tailored to roles within the medical technology industry. Each course is mastery-based, self-paced, interactive, and takes 30-45 minutes to complete. An AdvaMed certificate is awarded at the completion of the track.
The three tracks are:
- Corporate Compliance -- for compliance, legal and sales/marketing professionals.
Example topics include: Basics of AdvaMed Code, Introduction to Medical Device Compliance, FCPA/Global Anti-bribery, and HIPAA/Privacy Guidelines;
- RA/QA – for Medical Device regulatory and quality professionals.
Example topics include: Regulatory Filings: 510(k), PMA, and IDE, Introduction to Quality System Regulation (QSR), Handling a Product Recall, ISO 14155: Obligations of Sponsors & Monitors for Medical Device Trials;
- Medical Technology Overview – for Medical Device Industry Generalist
Example topics include: Global Regulatory Strategy and Planning for Medical Devices, FDA Inspections, and Complaint Management.
“The launch of the ARCC program is a relevant and timely collaboration of our long-standing partnership with AdvaMed. We have worked side by side with AdvaMed over the years to support the medical technology community through thought leadership and relevant educational outreach and compliance programs,” noted Lisa Clune, UL EduNeering’s President. “Today’s medical technology organizations demand mastery of specific regulatory compliance and quality issues to remain competitive. Participation in the certificate program sends a clear signal to employers, clients and constituents that professionals are committed to the industry.”
Added Stephen J. Ubl, president and CEO of AdvaMed, “Supporting professional education in the rapidly-changing medical technology industry is a core part of AdvaMed’s mission. We are pleased to partner with UL EduNeering to offer this very timely and important program.”
As the exclusive online training partner for compliance solutions to AdvaMed, UL EduNeering brings its years of proven enterprise-wide compliance management experience to the medical technology industry.
About UL EduNeering
UL EduNeering (www.uleduneering.com) is part of UL (Underwriters Laboratories), a global independent safety science company offering expertise across five key strategic businesses: Product Safety, Environment, Life and Health, Knowledge Services and Verification Services.
UL EduNeering develops technology-enabled solutions for improving business performance and assuring regulatory compliance. For more than 30 years, the company has served corporate and government customers in the Life Science, Health Care, Energy and Industrial sectors using proprietary learning management platforms that integrate business, learning and technology.
UL is a premier global safety science company with more than 100 years of proven history. Employing nearly 9,000 professionals in 46 countries, UL is evolving the future of safety with five distinct business units – Product Safety, Environment, Life & Health, Verification and Knowledge Services – to meet the expanding needs of customers and the global public. For more information on UL’s family of companies and network of 95 laboratories, testing and certification facilities, go to UL.com.
AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit www.advamed.org
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Source: UL EduNeering