Understanding ISO 13485 and its Relation to FDA's Quality Systems Regulation

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

Instructor Profile:

Jessica Czamanski’s expertise includes technical writing, QMS auditing, English-Spanish translation of technical documents, regulatory submissions (510(k), PMA, Technical Files, Design Dossier), documentation control, process validations, supplier audits, risk management activities, and creation and implementation of QMS for ISO 9001, 13485, and 21 CFR 820. She is a biomedical engineer with vast experience in quality and regulatory affairs for medical devices.

Topic Background:

ISO 13485 is the international standard for quality management systems for medical device manufacturers and service providers. This standard, which derived from ISO 9001 Quality Management Systems and incorporated additional requirements specific for medical device manufacturers, is globally recognized and used by medical device manufacturers. In the United States, the FDA’s Code of Federal Regulation (CFR), Title 21 Part 820, is the Quality Systems Regulation and contains the Good Manufacturing Practices (GMPs) that is used to ensure the safety and effectiveness of medical devices. The QSR includes most of the same requirements as ISO 13485 and a few additional requirements as well. All medical device manufacturers who produce medical devices to be sold and marketed within the United States must comply with the QSR. Similarly, the purpose of ISO 13485 is to achieve consistency in medical device services provided to meet customers’ requirements, while complying with applicable regulations.

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