The audit served to assess ISS’ adequacy and quality level in order to assure that the systems, procedures, practices and documentation at the CRO comply with Good Clinical Practice (ICH GCP), relevant national and international GCP requirements, CRO policies and procedures, and generally accepted good practices.
«For any Medtech company, and especially for startups, regulatory affairs are topics which are absolutely essential but not easy to deal with. All these directives, paragraphs and standards reveal details which are easily underestimated and could potentially have a huge impact on strategic steps towards...»
ISS-Talk at the Tuttlinger Innovationsforum on October 19th
02 August 2017
Digital Regulatories is a hot topic....
3D Printing, impact of MDR
25 June 2017
ISS CEO Hansjörg Riedwyl is a...
Formation – Évaluation clinique selon MEDDEV 2.7/1, Révision 4
02 March 2017
ARIAQ et ISS AG proposent une...
MDR event with participation of ISS
09 February 2017
At the first Swiss Medtech Conference...
Further clinical evaluation of ISS AG meets the requirements
26 January 2017
The process established by ISS AG...
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