Aurélia

Aurélia is specialized in giving in-depth advice in relation to regulatory compliance and quality.

Medical devices and IVDs (incl. software):

* Request export certificates (Certificate of a Medical Device, FAGG)
* Request CE-mark
* Supplier Management
* Quality Management System related processes
* Lean manufacturing
* Quality Risk Management
* FMEA
* Root Cause Analysis
* ISO 13485 (2003, EN 2012, 2016)
* ISO 9001 (2008, 2015)
* ISO 18113:2011
* ISO 14971:2012
* MEDDEVs
* Directive 98/79/EEC ; 93/42/EEC ;
* Labeling
* Validation
* CAPA
* Change Control
* Internal audit planning
* Document Control
* QMS GAP analysis
* ISO certification
* FDA
* HIPAA

Company’s Keywords:

drugs, medical device, cosmetics, risk management, regulatory compliance, food, quality assurance, pharmaceuticals