Quality System Requirements. 7.1. Manufacturer shall obtain and maintain all registrations and approvals necessary to manufacture Customer’s Product. Manufacturer must remain compliant with the requirements set forth in 21 U.S.C. § 360J (f), 21 C.F.R. § 820, all related guidance issued by the FDA, ISO 13488 and/or ISO 13485 (collectively, “Good Manufacturing Practices”). Manufacturer’s performance of this Agreement shall be in compliance with these Good Manufacturing Practices.
Appears in 2 contracts
Samples: Contract Manufacturing General Agreement, Contract Manufacturing General Agreement (Salient Surgical Technologies, Inc.)
Quality System Requirements. 7.1. 7.1 Manufacturer shall obtain and maintain all registrations and approvals necessary to manufacture Customer’s Product. Manufacturer must remain compliant with the requirements set forth in 21 U.S.C. § 360J (f), 21 C.F.R. § 820, all related guidance issued by the FDA, ISO 13488 and/or ISO 13485 9001 and EN46001 (collectively, “Good Manufacturing Practices”). Manufacturer’s performance of this Agreement shall be in compliance with these Good Manufacturing Practices.
Appears in 1 contract
Samples: Contract Manufacturing General Agreement (Salient Surgical Technologies, Inc.)
Quality System Requirements. 7.1. 8.1 Manufacturer shall obtain and maintain all registrations and approvals necessary to manufacture Customer’s Product. Manufacturer must remain compliant with the requirements set forth in 21 U.S.C. § 360J (f), 21 C.F.R. § 820, all related guidance issued by the FDA, ISO 13488 and/or ISO 13485 (collectively, “Good Manufacturing Practices”). Manufacturer’s performance of this Agreement shall be in compliance with these Good Manufacturing Practices.
Appears in 1 contract
Samples: Contract Manufacturing General Agreement (Salient Surgical Technologies, Inc.)
