ISO 13485, ISO 14971, Quality Document Management, and Risk Management for Medical Devices 2017

Topics

• Inputs into a Quality and Regulatory Management System
• Understand and implement a document naming convention for their department, pursuant to sections in ISO 13485
• Incorporate the approach as a new discipline for all current and new staff joining the organisation
• Procedural approach when documents are saved and are continuously traceable from the time they are first created
• Immediate time savings when the approach is continuously used
• Continuous use of the new procedure through ongoing audits of the practice throughout the organisation
• Remain compliant to ISO 13485
• A clearly defined document indexed maintainable folder structure

Who should Attend

• Quality professionals
• Senior quality managers
• Compliance professionals
• Regulatory professionals
• Manufacturing engineers
• Production supervisors
• Design engineers
• Production engineers
• Quality engineers
• Process owners
• Document control specialists
• Quality auditors
• IT Managers and associated staff
• Administrative staff