New Certificate Program Available for Medtech Professionals

Healthcare professionals understand the importance of educating themselves to stay abreast of emerging technologies, biomedical research findings and clinical studies. It is nearly impossible for practitioners to stay current on every new U.S. Food and Drug Administration (FDA) guidance document or ISO certification standard.

Thus the need for continuing education (CE). Refresher courses and certificate programs enable doctors, nurses, laboratory technicians and other healthcare workers to learn about the latest medical treatments or equipment. And while they mostly are used by those providing treatment, CE programs are equally as important to those that devise the treatment delivery methods.

To address the CE needs of medtech professionals, the Advanced Medical Technology Association (AdvaMed) and UL EduNeering have created and launched a new online certificate program. The AdvaMed Regulatory and Compliance Certificate (ARCC) program provides industry professionals with the latest information on “relevant medical device issues” and FDA regulations as well as practical information and job skills.

“Supporting professional education in the rapidly-changing medical technology industry is a core part of AdvaMed’s mission,” AdvaMed CEO Stephen J. Ubl said. “We are pleased to partner with UL EduNeering to offer this program.”

The ARCC offers three separate program options (tracks) and leverages UL EduNeering’s online libraries, including both FDA and AdvaMed-approved content (UL EduNeering is part of Underwriters Laboratories, a global independent safety science company). Each ARCC track includes three to four required courses and six to seven electives, which are tailored to specific roles within the medtech industry. Each course is master-based, self-paced, interactive, and takes 30 to 45 minutes to complete, according to a news release about the program. An AdvaMed certificate is awarded at the completion of each track.

The three tracks are:

• Corporate Compliance—designed 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—designed 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—designed for those who may be new to the device industry or whose job requires broad knowledge of several key areas. 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,” UL EduNeering President Lisa Clune noted. “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. 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.”

For details of the program or to enroll in a course, visit
www.advamedcertificate.org.