ISO 13485 is the International Standard that specifies the regulatory requirements for medical device Quality Management System (QMS). The purpose of this webinar on ISO 13485 is for Quality management system implementers,Quality/regulatory managers and bio medical auditors’ and auditors from Food/Pharma(who are hoping to make the transition into the medical device arena) to gain a thorough understanding of the requirements of ISO 13485 to:
Carefully attend to every aspect of the standard requirements for their medical devices in their QMS
Establish internal standard practices to fulfill the requirements of the standard
Consistently meet and exceed customer and regulatory requirements per this international standard for their medical devices
Understand how your commitment to these ISO standard requirements will facilitate your navigating your way through the harmonized international arena to expand your product marketing strategies at a global level from countries such as Canada, Australia, Brazil, India and China.
You will gain a thorough insight into the specific auditing requirements of the International ISO 13485 Standard requirements for medical devices. This class will truly build your knowledge from the fundamental principles and help you grow into fulfilling the regulatory requirements as a product developer, manufacturer, auditee for external FDA type of audits and serve as an auditor (internal or supplier auditor). The webinar will also focus on the major difference in expectations between FDA Quality System Regulations and Quality System inspection Techniques (QSR and QSIT) and ISO 13485 for globally distributed products.
Areas Covered in the Session :
Fundamental requirements of ISO 13485 and related biomedical standards that medical device companies need to comply with for key areas like:
Identification and Traceability
Post Market Surveillance.
How does ISO 13485 differ from FDA QSR 21 CFR 820 requirements ?
Regulatory expectations of other major growing geographies in the world and how these markets can be prepared to be audited to fulfill ISO 13485 expectations and conduct audits for ISO 13485 Requirements.
Who Will Benefit:
This course will be especially helpful to auditors who would like a deeper understanding of the ever growing medical device regulations particularly those who transitioned from other regulated industries such as pharma/nutraceuticals and food industries and Quality/Regulatory Managers, Supervisors, Department leads, Manufacturing Engineers associated with
Suppliers to medical device industry
Supply Chain Auditors
Production Leads and Managers