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ISO 13485 Certification

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ISO 13485 Certification

One of the most popular international quality system standards for medical devices are issued by the International Organization for Standardization (ISO) - ISO13485, which includes all the elements of ISO9001 plus a set of supplementary requirements for m

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Business 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.

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.

FAQ

Why do we need to implement ISO 13485?

- Potentially gain entrance into international markets since certification to ISO 13485 is seen as a first step toward achieving compliance with European regulatory requirements.

- Help protect your organization’s financial investment through harmonized quality management system requirements for regulatory purposes.

To meet the requirements of ISO13485 is equivalent to FDA?

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

Why Choose World Center for Certification & Quality

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

World Center for Certification & Quality Certification is recognized by more than 40 national and international accreditation bodies across the world.

Mark of global recognition

The World Center for Certification & Quality Certification mark is a globally recognized symbol of your organization’s ongoing commitment to excellence, sustainability and reliability.