Quality management

ISO 9001:2015 and EN ISO 13485:2016 certification

The entire AO Research Institute Davos (ARI) is certified according to ISO 9001:2015 and we have good reason to be proud of this. AO Research Institute Davos is one of very few academic research organizations to have achieved this certification.

Additionally, the biomechanics and modeling, and concept development focus fields are certified according to EN ISO 13485:2016, which demands a much higher level of documentation and traceability.

Good Laboratory Practice (GLP) certification for our Preclinical Facility

High-quality work is important for successful research. AO Research Institute Davos works hard to ensure the highest quality in all our research projects. Therefore, we are very proud to have received the official Statement of GLP Compliance from the Federal Office of Public Health, of the Swiss Confederation through Swissmedic (Swiss Agency for Therapeutic products), together representing the Swiss GLP monitoring authorities, in October 2018. AO Research Institute Davos is one of only two academic institutes certified for GLP in Switzerland.

These accreditations demonstrate AO Research Institute Davos's commitment to fulfilling the highest standards in research.

The GLP is an internationally recognized quality system concerned with the organizational process and conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived, and reported.

We are now able to conduct preclinical studies with potential customers and any partners of the AO network in the only Swiss GLP and AAALAC accredited institute. This is of special importance, for future approval of medical devices by the FDA, since the FDA has new guidelines in review (general considerations for animal studies for medical devices) for preclinical studies, which will make GLP and AAALAC virtually mandatory for any submission to the FDA.

ISO 9001:2015 and EN ISO 13485:2016 certification

The entire AO Research Institute Davos (ARI) is certified according to ISO 9001:2015 and we have good reason to be proud of this. AO Research Institute Davos is one of very few academic research organizations to have achieved this certification.

Additionally, the biomechanics and modeling, and concept development focus fields are certified according to EN ISO 13485:2016, which demands a much higher level of documentation and traceability.

Contact

Ulrich Bentz

Quality Management and Procurement

 

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