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Support for ISO 13485 - Medical Device Industry

Support for ISO 13485 and FDA Regulated Industries

SAI Global's comprehensive ISO 13485 and regulatory support program for the Medical Device Industry enables your organization to implement an effective ISO 13485 quality management system and meet domestic and international regulations for medical device, while achieving overall business improvement.

Course Title	Course Schedule	At Your Location
RABQSA Certified Lead Auditor with Specific Reference to FDA Regulated Industries (ISO 13485, ISO 9001)	Schedule	Quote
Internal Auditor Training for FDA Regulated Industries (ISO 13485:2003 and ISO 9001:2000)	Schedule	Quote
Understanding and Implementing the ISO 13485 Standard	Schedule	Quote
Quality System Regulations (QSR) for the Medical Device Industry	Schedule	Quote
Design Control for the Medical Device Industry	Schedule	Quote
Risk Management / Risk Analysis for Medical Devices	Schedule	Quote
Process Mapping	Schedule	Quote
Corrective and Preventive Action	Schedule	Quote
Skills for Success for the Management Representative	Schedule	Quote
CE Marking for the EU Medical Device Directives	Schedule	Quote
Understanding FDA Regulations for Combination Products		Quote
Effective Corrective And Preventive Action for FDA Regulated Industries		Quote
Incorporating Supplier Quality Management Techniques in FDA Regulated Businesses		Quote
Employee Awareness (Medical Device and Pharmaceutical)		Quote
Executive Overview (Medical Device and Pharmaceutical)		Quote

"What I really took away from this course is a much better understanding of the medical device industry system, nationally and internationally. I'm new to this industry so this course was a very good introductory course to quality system management."
--Lucy Kong, Boston Scientific Corp, Target Therapeutics

Our ISO 13485 training courses include ISO 13485 training for implementation, ISO 13485 training for internal auditors, and lead auditor training for FDA regulated industries.

Medical/Regulatory Brochure

Download our business performance and regulatory compliance brochure.

Course Calendar

For a comprehensive listing of training dates and locations, view our online course calendar.

Want more information about our ISO 13485 - FDA Regulated Industries training program? Need ISO 13485 - FDA Regulated Industries on-site training or specialized support? Submit an ISO 13485 - FDA Regulated Industries inquiry, or call us at 1-800-374-3818.