ISO 13485 Pdf

ISO 13485: Medical Devices Quality

Boost quality and meet medical devices industry requirements

Medical Devices Industry Challenge

Meeting legislative regulations and customer requirements for the manufacture and sale of medical devices in a global marketplace can be confusing. With so many regulations, differing from country to country, an organization must address a complex array of quality, process, and management issues in order to compete internationally.

What is ISO 13485 Certification?

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. 

It is important to note that being certified to ISO 13485 does not fulfill the requirements of either the FDA or foreign regulators; however, the certification provides a solid framework on which to build compliance to various regulatory and customer requirements.

Why Choose Bureau Veritas?

Network

5,700 skilled auditors operating in more than 100 countries offer a unique combination of international and local expertise providing consistent services wherever our clients are. 

Expertise

Our auditors have extensive knowledge of specific industry sectors, local regulations, markets and language that enables them to provide solutions adapted to your needs. 

Recognition

Bureau Veritas Certification is recognized by more than 40 national and international accreditation bodies across the world. 

Mark of global recognition

The Bureau Veritas Certification mark is a globally recognized symbol of your organization’s ongoing commitment to excellence, sustainability, and reliability.

ISO 9001 FAQ - Frequently Asked Questions

  • What are the key benefits of implementing 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.

  • Does ISO 13485 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.

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