Up to the mark for medical device design
A
Sagentia product story
Edited by the Engineeringtalk editorial team
Feb 8, 2008
Sagentia now has the ability to provide medical device design services that consistently meet both customer and regulatory requirements.
Sagentia has been awarded certification to ISO13485:2003, the internationally recognised standard for ensuring adherence to regulatory requirements in the medical device industry.
As a registered organisation, the standard acts as a stamp of approval in an international marketplace for Sagentia, demonstrating an ability to provide medical device design services that consistently meet customer and regulatory requirements.
It also enhances Sagentia's ISO9001:2000 certification, allowing the medical device requirements to work within the organisation's existing quality management system, and benefiting clients by ensuring the highest quality standards are met.
Jo Morgan, Quality Manager at Sagentia, says: "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 deliver products that are both safe and effective.
ISO13485:2003 focuses on achieving, maintaining and improving compliance with the industry requirements and allows companies that design and develop medical devices to market their products around the world with greater confidence.
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