ISO 13485: Quality Management System for Medical Devices 2017 is a conference dedicated to an overview into the use of ISO 13485 as the basis for a Quality Management System (QMS) for medical device manufacturers.
ISO 13485: Quality Management System for Medical Devices 2017 covers topics such as:
- Compare the requirements of ISO 13485 and ISO 9001 and update on the ISO 9001:2015 revisions
- Introduction to ISO 13485
- How to achieve ISO 13485 accreditation
- Interpretation of ISO 13485 and what it means in practice
- Understanding the roles and responsibilities of quality management in ISO 13485
- Examples of ISO 13485 non-compliance
- Compare and contrast the requirements between ISO 13485 and FDA’s Quality System Regulation
- The relationship between ISO 13485 and ISO 14971 ‘Application of Risk Management to Medical Devices’
- Unannounced Audits – what to expect
- Update on the next revision ISO 13485: 2015
- Benefits from implementing a QMS
- Successful handling of complaints
ISO 13485: Quality Management System for Medical Devices 2017 brings together:
- Quality Assurance Personnel
- Quality Managers
- Internal and External Auditors
- Regulatory Affairs Managers
- All those who are involved with the implementation
- Medical Device Designers and Developers