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Article

Sagentia reaches high standard for medical devices

This article has been taken from The Gen newsletter - Spring 2008. Click here to download the pdf.

Sagentia has been awarded certification to ISO 13485:2003, the internationally recognised standard for ensuring adherence to regulatory requirements in the medical device industry.

The standard demonstrates an ability to provide medical device design services that consistently meet customer and regulatory requirements. It also enhances Sagentia's ISO 9001:2000 certification, allowing the medical device requirements to work within our existing quality management system, and benefiting clients by ensuring the highest quality standards are met.

Jo Morgan, Quality Manager at Sagentia, comments: 'Having already received registration to 9001:2000 and having an established Quality Management System made the job a little easier as we had already documented many of the requirements included in the standard. The challenge is in ensuring that everyone knows what to do and is capable of operating effectively within the requirements. This registration demonstrates our commitment to providing the highest quality technology development services to our clients'.

Medical device manufacturers are required to deliever products that are both safe and effective. ISO 13485:2003 allows companies that design and develop medical devices to market their products around the world with greater confidence.
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