FDA QSR definition
Examples of FDA QSR in a sentence
The parties' objective is that Pilot Instruments will be manufactured to the same FDA QSR configuration control standards as Production Instruments.
Animas and Debiotech shall cooperate in the preparation of, and shall execute, as part of the Development Program, a Quality Agreement in order to meet the requirements of ISO13485, European MDD and FDA QSR (21 CFR 820) requirements for medical devices, to the extent applicable.
GBI warrants to ATS that the Products sold to ATS under this Agreement will meet the then current Preliminary Specifications or Specifications for Products, as the case may be, and will be free from defects in design, manufacturing, materials and workmanship under normal intended use and service, in accordance with all applicable FDA, QSR, and CE standards and requirements for a period of twelve (12) months from the date of delivery to ATS.
QSR Quality system regulations as defined by 21 CFR Part 820 GMP Good Manufacturing Practices as defined by the FDA QSR Packaging Material Any material employed in the packaging of a product, excluding any outer packaging used for transportation or shipment.
Seller warrants that (a) it will manufacture the Product in accordance with Specifications, FDA QSR (21 CFR 820), and ISO 13485, (b) all Product will meet Specifications at the time of delivery to Buyer, and (c) all Product will have a shelf life of at least twelve (12) months at the time of delivery to Buyer and (d) Buyer will acquire good title to the Product at the time of delivery to Buyer, free and clear of all Encumbrances.
Manufacturer — the natural or legal person responsible for defined manufacturing activities related to a device with a view to its being placed on the market under the manufacturer’s own name in compliance with the Medical Device Directives and FDA QSR 21 CFR Part 820.
Tandem hereby warrants and covenants that it has established and will maintain quality management systems in respect of the design, manufacture, quality assurance and testing of the T:Slim System which have been and will remain in compliance with FDA QSR requirements.
The parties’ objective is that Pilot Instruments will be manufactured to the same FDA QSR configuration control standards as Production Instruments.
NOVA will maintain the DMR and all associated documentation in compliance with FDA QSR requirements and ISO 13485 standards, and shall make the DMR available (including electronic copies thereof) to Cerus on request.
CCSI warrants that the Products shall be free from defects in material and workmanship and will conform to the Specifications (which among other things include that the manufacture, assembly, labeling and packaging of the Products have been performed under the regulatory standards of FDA QSR and GMP), in each case for a period of * from the date of shipment to DO of Products hereunder.