Certification Status. Both parties agree to maintain ISO900x, 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 2 contracts
Samples: Development and Purchase Agreement (Aspect Medical Systems Inc), Development and Purchase Agreement (Aspect Medical Systems Inc)
Certification Status. Both parties agree to maintain ISO900xmaintain, 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
Samples: Purchase and License Agreement (Aspect Medical Systems Inc)
Certification Status. Both parties agree to maintain ISO900xmaintain, EN460xas 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 ’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
Samples: Bisx International License Agreement (Aspect Medical Systems Inc)
Certification Status. Both parties Parties agree to maintain ISO900x, 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 all other appropriate applicable U.S. and international regulations pertinent to the development, manufacturing and marketing of medical products similar to the Aspect CDIC Products.
Appears in 1 contract
Samples: Development and Purchase Agreement (Cardiodynamics International Corp)
Certification Status. Both parties agree to maintain ISO900xmaintain, 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 Administrations ("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
Samples: Development and Purchase Agreement (Aspect Medical Systems Inc)
Certification Status. Both parties agree to maintain ISO900xmaintain, EN460xas 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
Samples: Development, and Supply Agreement (Aspect Medical Systems Inc)