PLANT INSPECTION. Arthrex shall have the right to have qualified Arthrex employees, contractors or agents present at Bovie's manufacturing facility, at mutually agreeable times during normal business hours to (i) observe Bovie's manufacture of Products; (ii) inspect Bovie's facility and manufacturing procedures, as such relate to Products manufactured hereunder, and quality assurance/control procedures for compliance with (A) QSR, including GMP, as well as 180- 9001 registrations (provided and for such time that such standards remain valid) and EN 46001 certification, (B) ETL standards for testing and evaluation of each of the Products and (C) compliance with the ED Medical Device Directives in connection with the CE Marking; and (iii) inspect Bovie's inventory, work-in-process, raw materials, QSR records and such other matters as may be pertinent to proper quality assurance of Products to be delivered under the terms of this Agreement.
Appears in 3 contracts
Samples: Manufacturing Agreement (Bovie Medical Corp), Manufacturing Agreement (Bovie Medical Corp), Manufacturing Agreement (Bovie Medical Corp)
PLANT INSPECTION. Arthrex shall have the right to have qualified Arthrex employees, contractors or agents present at Bovie's manufacturing facility, at mutually agreeable times during normal business hours to (i) observe Bovie's manufacture of Products; (ii) inspect Bovie's facility and manufacturing procedures, as such relate to Products manufactured hereunder, and quality assurance/control procedures for compliance with (A) QSR, including GMP, as well as 180- 9001 ISO-9001 registrations (provided and for such time that such standards remain valid) and EN 46001 certification, (B) ETL standards for testing and evaluation of each of the Products and (C) compliance with the ED EU Medical Device Directives in connection with the CE Marking; and (iii) inspect Bovie's inventory, work-in-process, raw materials, QSR records and such other matters as may be pertinent to proper quality assurance of Products to be delivered under the terms tea's of this Agreement.
Appears in 2 contracts
Samples: Original Equipment Manufacturer Agreement (Bovie Medical Corp), Original Equipment Manufacturer Agreement (Bovie Medical Corp)