ISO 13485 Quality Management System
Duration: 60 Minutes
Organizations wishing to market Medical Devices in Europe must develop Quality Management Systems in accordance with ISO 13485. Such Quality Systems will also be beneficial for organizations seeking to gain marketing permission from the FDA.
ISO 13485 is becoming the de facto international regulatory requirement for Medical Device manufacturing. Introduced in Europe as one of the requirements to obtain CE Marking for products, it has also gained acceptance within the FDA.
Why Should you Attend:
Medical Device manufacturers must document and implement processes for Corrective and Preventive Actions (CAPA) to comply with Quality System and Regulatory requirements. These processes include those to adequately measure, analyze, and improve nonconformities identified through any number of sources. Organizations must also develop preventive action processes to address potential nonconformities of systems, processes or products.
Objectives of the Presentation:
Who can Benefit:
- Overview of ISO 13485 Quality Management System
- Discussion of key requirements
- What written procedures and training are required
- How should internal audits be conducted
- Understanding of what auditors expect
- Quality Assurance Managers/Personnel
- Regulatory Managers/Personnel
- Manufacturing managers, supervisors & personnel
- Internal Auditors
- Senior management executives (CEO, COO, CFO, etc.)
- Project Managers