This webinar will highlight the distinctions between ISO 13485 and FDA’s QSR. It will further introduce attendees to key clauses and requirements pertaining to the two regulations and also detail internal audit requirements.
This session will explore the key concepts of QMS for medical device manufacturers and FDA’s QSR (Quality Systems Regulation), while providing various examples for better understanding and compliance.
The primary objective of this webinar is to provide attendees a fundamental understanding of the basics of a quality management system for medical device manufacturers as stipulated by FDA and ISO 13485.
Additionally, this webinar will also provide valuable assistance to:
Why Should You Attend:
Quality management systems (QMS) are expected to be successfully implemented by all medical device manufacturers registered with the FDA. Therefore, most personnel involved directly or indirectly in manufacturing of medical devices will have to work in a regulated environment and follow specific procedures to perform some if not all of their job functions. This presentation will provide general understanding of ISO 13485, 21 CFR 820, and their differences.This session will explore the key concepts of QMS for medical device manufacturers and FDA’s QSR (Quality Systems Regulation), while providing various examples for better understanding and compliance.
The primary objective of this webinar is to provide attendees a fundamental understanding of the basics of a quality management system for medical device manufacturers as stipulated by FDA and ISO 13485.
Areas Covered in the Webinar:
- Concept of quality management system
- All clauses in ISO 13485
- Auditable clauses of ISO 13485
- All parts of the FDA’s QSR
- Who is responsible for complying with QSR
- Differences between ISO 13485 and QSR
- Role of management in quality
- Exclusions from specific parts of the regulation or standard
- Internal audit requirement
Who Will Benefit:
This webinar will guide recent graduates looking to work in the medical device industry, individuals working in the medical device industry for the first time, and entrepreneurs and small business owners who wish to register with the FDA and manufacture medical devices.Additionally, this webinar will also provide valuable assistance to:
- Medical device manufacturers
- R&D teams for medical devices
- Personnel involved in the packaging of medical devices and packaging engineers
- Inventory control personnel in a medical device company
- Quality personnel and quality engineers
- Suppliers to medical device companies
- Biomedical engineers
- Manufacturing engineers
Course Provider
Jessica Czamanski,
