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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
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