Certification Status. Both parties agree to maintain, as applicable, ISO900x or ISO13485, European directive 93/42/EEC Annex II ("MDD AX-II") certification status and compliance with the U.S. Food and Drug Administration's ("FDA") Quality System Regulation ("QSR"), the European Medical Device Directive ("MDD"), and other appropriate regulations pertinent to the development, manufacturing and marketing of medical products similar to the Aspect Products.
Appears in 1 contract
Sources: Bisx License, Development, and Supply Agreement (Aspect Medical Systems Inc)
Certification Status. Both parties agree to maintain, as applicable, ISO900x or ISO13485, EN460x, European directive 93/42/EEC Annex II ("MDD AX-II") certification status and compliance with the U.S. Food and Drug Administration's ("FDA") Quality System Regulation ("QSR"), the European Medical Device Directive ("MDD"), and other appropriate regulations pertinent to the development, manufacturing and marketing of medical products similar to the Aspect Products.
Appears in 1 contract
Sources: Development, Purchase and License Agreement (Aspect Medical Systems Inc)