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

April 8, 2015

Strongman Run and Berlin Marathon 2015

September 2015, name it at Factory-CRO and most of the employees will tension their muscles in a reflex. Why? A group of 10 persons is currently training towards the Marathon of Berlin (27 September 2015) and the Fisherman’s Friend Strongmanrun...

Factory
April 6, 2017

Medical apps under the new European MDR

Worldwide 1 out of every 3 internet users currently monitors their health or fitness using an app. This was shown in a recent survey by market researcher GfK. Millions of health-related apps are downloaded every year, and this is expected...

Starter
Regulatory
Pre Market
December 30, 2016

Notified bodies under pressure

After our recent posts on the proposed Medical Device Regulation (MDR) and MEDDEV 2.7/1 rev. 4, it is interesting to shift our perspective, aiming to get a sense of the potential impact of the new regulatory framework for the medical...

Advanced
Regulatory
Life Cycle