Anne Pauline van der Wilden

May 4, 2016

DEKRA audit 2016

On May 3rth, 2016, Factory CRO was audited based upon the ISO13485:2003 and ISO9001:2008 audit criteria by the DEKRA. We are happy to announce that, again, zero major and zero minor nonconformities were identified.

“I am very happy with the result of this audit. Throughout the years we have put a lot of effort in the organization to achieve this level of quality awareness. The acknowledgement through outcome of this audit is therefore a welcome reward.”

– Anne Pauline van der Wilden-van Huijstee, Quality Assurance Manager

About the author

Anne Pauline van der Wilden

May 4, 2016

DEKRA audit 2016

On May 3rth, 2016, Factory CRO was audited based upon the ISO13485:2003 and ISO9001:2008 audit criteria by the DEKRA. We are happy to announce that, again, zero major and zero minor nonconformities were identified. “I am very happy with the result...

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Factory
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As of TODAY you can collect clinical device data for your IDE or PMA outside of the USA

A year ago, the FDA published their final rule on the acceptability of medical-device clinical data collected outside of the USA (OUS) to support an IDE or device marketing application (1). Published in February 2018, the effective date of the...

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VIDEO: Factory CRO Group

Medical device company looking to partner with a global CRO but do not want a generic approach to your clinical trial? At Factory-CRO Group we are focused, efficient and flexible and pride ourselves in creating a custom plan for each...

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