ISO 13485 sets out the criteria for medical device quality management systems. It can be used by medical devices manufacturers, suppliers or any organization that can benefit in implementing the standard. The recently revised standard is based on a number of quality management principles focusing on how companies should manage risk-based decisions related to purchasing, design, development, manufacturing, production control activities and other aspects of quality management systems.
The webinar aims to help you understand how to achieve or maintain your organization’s ISO 13485 certification.
In this webinar session, the following topics will be discussed:
- ISO 13485:2003 non-conformance trends vs ISO 13485:2016
- ISO 13485:2016 global pain-point review and insights
- Distribution of audit non-conformities by section of the standard
- Section 7: Product realization
- Section 4: Quality management systems
- Section 8: Measurement, analysis and improvement
Charlene Rice – Global Product Manager, Medical Devices
Charlene has 13 years’ customer-facing experience within the certification and business enhancement division, auditing against the ISO 13485 standard and managing our global accreditation for the delivery of this scheme. In addition to ISO 13485, she is the lead auditor for the 93/42/EEC Medical Device Directive.
Prior in joining SGS, Charlene worked in the highly regulated pharmaceuticals, aerospace and automotive industry sectors.
ISO 13485 webinar is intended for any organization. It is particularly relevant for medical device manufacturers, suppliers and related parties who want to understand the changes and how to implement them successfully to continue to meet customer needs and comply with regulatory requirements.
Cost: No charge
For more information, please contact:
Senior Global Marketing Manager
t: +1 201 508 3000