This ISO 13485 requirements training will provide guidance to medical device companies in developing an adequate Quality Management System (QMS) in accordance with ISO 13485 and FDA expectations. This webinar will also benefit medical device companies that are planning to market their products in Europe.
This 90-minute webinar on quality management system for medical device manufacturers will focus on the key requirements of the ISO 13485 standard. It will also discuss the requirements for internal audit and how to meet the FDA medical device audit expectations.
Why Should You Attend:
Medical device manufacturers that are planning to market their products in Europe must develop a quality system in accordance with ISO 13485 to obtain a CE marking. It will also help to increase efficiency, cut costs and to meet customer satisfaction. Complying with ISO 13485 will aid in gaining marketing permissions and certification from FDA and achieving access to more markets across the globe.This 90-minute webinar on quality management system for medical device manufacturers will focus on the key requirements of the ISO 13485 standard. It will also discuss the requirements for internal audit and how to meet the FDA medical device audit expectations.
Areas Covered in the Webinar:
- 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.
Who Will Benefit:
- Medical Device Quality Assurance Managers/Personnel
- Medical Device Regulatory Managers/Personnel
- Medical Device Manufacturing managers, supervisors & personnel
- Internal Auditors
- Senior management executives (CEO, COO, CFO, etc.) of medical device companies
- Medical Device Project Managers
Course Provider
Peter Spath,
