Press release - RESTON, VA - August 2, 2011
RABQSA International Inc. (RABQSA), in conjunction with BSI Group America Inc., is pleased to announce the development of the Medical Devices competency unit (RABQSA-MD).
The Medical Devices competency unit has been created for individuals wishing either to become trained to audit to the Medical Devices Standard (ISO 13485) or simply to understand the requirements of a medical devices quality management system.
“We are very excited to launch the RABQSA TPECS Medical Devices competency unit,” said Omar Perez, BSI’s Director of Training. “This innovative product for the medical device market will enable organizations to easily prepare and demonstrate their ability to provide medical devices, and related services, while consistently meeting customer and regulatory requirements.”
The training module allows for more flexibility in course content and duration. BSI has taken advantage of this flexibility by developing a streamlined approach allowing individuals to expand their certification in fewer training days – from five days to four days. The TPECS modular approach also gives students the ability to expand their certification through taking additional subsets of courses.
To further enhance the student experience, BSI introduces the option to take in-class and re-take competency exams online. This provides a user-friendly interface, streamlined grading, and electronic certificate delivery.
BSI’s streamlined format for 13485:2003 includes three courses: Requirements, Internal Quality Systems Auditor, and Lead Auditor. These classes will be held in multiple U.S. locations beginning in August and will run until year-end. Additionally, the online exams will be available in the end of August via BSI’s Learning Management System.