ISO 13485
From Quality Management Systems
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Solution
ISO 13485 defines the requirements that medical device manufacturers must incorporate into their management systems in order to achieve compliance in the medical device industry. Based on ISO 9001, the emphasis on continual improvement is replaced with an emphasis on meeting regulatory and customer requirements, risk management, and maintaining effective processes, namely the safe design, manufacture, and distribution of medical devices.
Does ISO 13485 certification fulfill FDA requirements?
No. It is important to note that being ISO 13485 certified does not fulfill the requirements of either the FDA or foreign regulations; however, the certification provides a solid framework on which to build compliance to various regulatory and customer requirements.
Why Choose Bureau Veritas?
- We perform a systematic, independent audit of the management system to identify strengths and areas for improvement.
- We use a planned audit schedule to ensure the management system meets objectives and provides continual improvement in key areas.
- Our extensive auditor network helps reduce auditor travel costs.
- Certification from Bureau Veritas is recognized and well-respected globally.
What are the key benefits of ISO 13485?
- Potentially gain entrance into international markets since certification to ISO 13485 is seen as a first step toward achieving compliance with European requirements.
- Help protect your organization’s financial investment through harmonized quality management system requirements for regulatory purposes.
- Create a framework for implementing a systematic approach to monitoring your organization’s processes and your customer’s feedback.
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