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...

Starter
Factory
Pre Market
June 13, 2018

Five Corners joins Factory CRO

Bilthoven, Netherlands — Factory CRO, a leading global contract research organization (CRO) focused on medical devices and in vitro diagnostics (IVDs), has announced that Five Corners is joining Factory CRO. Five Corners is the premier device CRO in Australia, supporting the...

Starter
Factory
Pre Market
May 24, 2018

Post-market surveillance under a “522 order”: Why, how and what?

Company X has gained 510k clearance for their new heart valve, and was notified by the Food and Drug Administration (FDA) that post-market surveillance (PMS) is required. Why did they receive it, what is it and what does it mean,...

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Regulatory
Pre Market