Webinar on ISO 13485:2016 - Understanding the Changes And Requirements

This webinar is intended to help you get familiar with the changes in the recent 2016 March version of ISO 13485 including differences with ISO 13485:2003. This webinar will help you better understand, increase your awareness and familiarity with the recent ISO 13485:2016. This webinar will provide great opportunities to develop your insight on what is best for your business under limited resources and circumstances when considering implementing ISO 13485:2016 for regulatory and certification purposes. Areas Covered in the Session : Applicable Laws Regulations FDA Guidance Major Misconception Definitions ISO 13485 (March, 2016 version) Differences between ISO 13485:2003 and ISO 13485:2016 Common Non-conformances During Regulatory Audits Global Aspects of ISO 13485 Quality Management System (QMS) ISO 13485:2016 Transition for Regulatory and Certification Speaker’s PASS-IT Recommendations: Best Practices Who Will Benefit: CEOs VPs Compliance Officers Attorneys Regulatory Affairs Clinical Affairs Quality Assurance Research & Development Consultants Contractors/Subcontractors Anyone Interested in the ISO 13485:2016