Quality Management ISO 13485

Quality Assurance

Quality and Service since 1996.

Our key objective is to achieve the highest level of customer satisfaction. We do so by continuously looking at ways to improve the quality of our processes, products, and services including keeping up to date with the latest software standards. The result is a partner you can rely on for solid products that meet all your requirements for your medical imaging and information needs.

For over 18 years, aycan products and services have been relied on by hospitals and imaging centers around the world to support their critical work. Our ability to deliver the highest levels of quality and service to our customers is the result of the innovative, dedicated spirit of the company and our quality and process management system. This seamless process keeps aycan running efficiently and keeps product costs down for our customers.

As part of the process, aycan software is designed and developed using the latest technology, passing numerous quality assurance steps along the way. This includes product specific testing plans and patterns to guarantee stability and security, and a final standardized test before shipping. To ensure customer satisfaction, all aycan products are backed by immediate, live customer service and support.

 

Certificates and Documents

Here you will find links to all current certificates and documents:

Company and Product Certifications

aycan meets all regulatory requirements for the development of medical product. Following is a list of our current certifications:


aycan Zertifikate ISO 13485 und Anhang II
aycan certificates

ISO 13485 and annex II in the DQS database 

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aycan store FDA Dokument
aycan store

Entry Establishment Registration & Device Listing of the U.S. health authority FDA (Food and Drug Administration)

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aycan xray-print FDA Dokument
aycan xray-print

Entry Establishment
Registration & Device
Listing of the U.S.
health authority FDA
(Food and Drug
Administration)

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aycan OsiriX k063470 FDA Dokument
aycan workstation

Document 510(k) Summary of Safety and Effectiveness of the U.S. health authority FDA (Food and Drug Administration): k063470

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aycan OsiriX k103546 FDA Dokument
aycan workstation

Document 510(k) Summary of Safety and Effectiveness of the U.S. health authority FDA (Food and Drug Administration): k103546

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aycan mobile k122260 FDA Dokument
aycan mobile

Document 510(k)
Summary of Safety
and Effectiveness of
the U.S. health
authority FDA
(Food and Drug
Administration):
k122260

[read more]

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