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Subscribe NewsletterUnderstanding ISO 13485 vs. ISO 9001 for Successful QMS in Medical Device Industries
Product Id
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600186
Overview: ISO 13485:2003 is a quality management system standard specially written for the medical device industry and is on the U S Food & Drug Administration (FDA) list of recognized consensus standards.
Medical device firms certified to ISO 13485:2003 will find themselves very closely compliant with FDA’s Quality System Requirements under 21CFR 820. This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements.
Medical device firms certified to ISO 13485:2003 will find themselves very closely compliant with FDA’s Quality System Requirements under 21CFR 820. This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements.
Why should you attend: International interest in certified quality systems is increasing. Many foreign countries are now requesting medical device firms supply them proof of certification to ISO 13485:2003. To apply a CE mark under the Medical Device Directive, 93/42/EEC, certification to ISO 13485 is required in most cases. This presentation is an in-depth analysis of ISO 13485 with comparisons to ISAO 9001.
Areas Covered in the Session:
- Principles of ISO 13485:2003
- ISO 9001 & ISO 13485 Differences
- Risk Management & ISO 14971
- FDA’s MDR’s & EU Vigilance
- Design Control
- MDD 93/42/EEC & Essential Requirements
Who Will Benefit: Employees who will benefit include:
- Manufacturing & Design Engineers
- Marketing Product Managers
- Quality System Auditors
- Quality & Regulatory Professionals