Quality System Requirements. The Device has the following classifications for FDA, CMDR, and MDD classification. Device US Classification Canada Classification MDD Classification Resection Device II III IIb Table 2 - Device Classifications
Quality System Requirements. Quality system requirements are specified as part of 21 CFR Part 820, Quality System Regulation.
Quality System Requirements. Health Canada requires manufacturers of Class II, III and IV device to demonstrate that their devices are manufactured in accordance with internationally recognized standards. Demonstration of compliance with the quality system requirements will be required at the time an application is made for a medical device license.
Quality System Requirements. Bovie Medical Corporation (“Bovie”) has been certified to ISO13485
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 9001 and EN46001 (collectively, “Good Manufacturing Practices”). Manufacturer’s performance of this Agreement shall be in compliance with these Good Manufacturing Practices.
Quality System Requirements. 3.1.1. CM will maintain an FDA registered facility and ISO 13485 quality system certified by a Notified Body or CMDCAS Registrar for the manufacture of Products.
Quality System Requirements. It is expected that Xxxxx supplier shall have basic minimum quality management system implemented which is ISO 9001:2015 by accredited certification body or any other system approved by Xxxxx. Unless otherwise specified by Xxxxx following sequence shall be applied to achieve this requirement
Quality System Requirements. Seller shall provide within their quality management systems, as a minimum, provisions to comply with the following ISO 9001/AS9100 clauses:
Quality System Requirements. The contractor shall establish, maintain, and operate a quality system in accordance with ISO 9001:2015, or an equivalent quality system. The contractor shall provide the Government an overview of their quality management system plan and approach as a briefing at the PAC, to include FWS-I unique areas. Quality Assurance, including reliability shall be addressed at each contractually required review, to include Statistical Process Control (SPC), Pareto charts and other metrics employed by the prime contractor and their major suppliers to control critical processes. The contractor shall maintain a calibration system in accordance with ANSI/NCSL Z540.3-2006, ISO 10012-2003, or equivalent to ensure that all test/inspection, measurement, and diagnostic equipment, including all accessories and ancillary test equipment, are properly calibrated, identified by appropriate labeling, and are traceable to national measurement standards.
Quality System Requirements. Both Parties agree to the following listed responsibilities for all the operations that are marked with “√ “ in the respective column that bears their name. Ref Description of Activity M V 1.1 [***]
