davidvandelden

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

davidvandelden

June 22, 2016

Am I wearing a medical device?

Working in Factory CRO’s clinical operations team, it’s all about collecting data and setting up clinical trials. As a movement scientist I was used to collect my own personal data during my training in university, but the new Garmin watch...

Starter
Regulatory
Pre Market
October 26, 2017

Factory CRO Acquires MileStone Research Organization, Builds North American Presence

Bilthoven, Netherlands — Factory CRO, a leading global contract research organization focused on medical devices and IVDs, has announced the acquisition of MileStone Research Organization. MileStone, located in San Diego, specializes in clinical research and reimbursement solutions for the medical device...

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Factory
Pre Market
September 6, 2017

Unique Device Identification (UDI) System – Path toward Global Harmonization?

On Sept. 24, 2013, the Food & Drug Administration (FDA) mandated 78 FR 58786 (the UDI Rule), herewith establishing a unique device identification labeling system in line with the requirements of 21CFR830.20. Medical device labelers must submit product information to...

Starter
Regulatory
Life Cycle