Quality System Regulation Sample Clauses

Quality System Regulation. Lake Region warrants that it will manufacture the Product in accordance with current Quality System Regulations (“QSR”) for medical devices as mandated by the FDA and in compliance with International Standard ISO 13485 and with any and all other applicable federal, state and local laws, rules, and regulations.
AutoNDA by SimpleDocs
Quality System Regulation. To the Knowledge of Seller, the Company has designed and developed the LipoSonix Product and all other Products in commercial distribution in material compliance with the applicable provisions of the Quality System Regulation set forth in 21 C.F.R. § 820.30, including Design Control provisions.
Quality System Regulation. The Supplier and the Customer shall each maintain a Quality Management System (QMS) that conforms to the requirements of the FDA’s Quality System Regulation (QSR) as stated in 21 CFR Part 820. Should the Supplier determine that a requirement of 21 CFR Part 820 is not appropriate or not applicable to the product delivered, the Supplier shall notify the Customer within thirty days of making that determination. The list of agreed not appropriate or not applicable requirements is shown in Appendix 1.
Quality System Regulation. ZIEN and CPI shall each maintain a Quality Management System (OMS) that conforms to the requirements of the FDA's Quality System Regulation (QSR) as stated in 21 CFR Part 820. Should ZIEN determine that a requirement of FDA 21 CFR Part 820 is not appropriate or not applicable as detailed in this agreement to the product delivered, ZIEN shall notify CPI within thirty (30) days of making that determination. The list of processes performed by ZIEN which are applicable to the manufacture of the LockeT Suture Retention Device is shown in Annex 1. Quality Agreement ISO 13485:2016 ZIEN and CPI shall each maintain a Quality Management System (OMS) that conforms to the requirements of ISO 13485:2016. ZIEN shall register the QMS with a registrar and maintain active certification. ZIEN shall provide a copy of the registration certificate to CPI. Should ZIEN determine that a requirement of ISO 13485:2016 is not appropriate or not applicable to the product delivered, ZIEN shall notify CPI within thirty days of making that determination. The list of processes performed by ZIEN which are applicable to the manufacture of the LockeT Suture Retention Device is shown in Annex 1.
Quality System Regulation. The Customer shall maintain a Quality Management System (QMS) that conforms to the requirements of EN ISO 13485:2003. Supplier is NOT required to meet EN ISO 13485, but is required to meet ISO 9001:2015 and the requirements specified in this Quality Agreement.

Related to Quality System Regulation

  • Quality Standards Each Party agrees that the nature and quality of its products and services supplied in connection with the other Party's Marks will conform to quality standards set by the other Party. Each Party agrees to supply the other Party, upon request, with a reasonable number of samples of any Materials publicly disseminated by such Party which utilize the other Party's Marks. Each Party will comply with all applicable laws, regulations, and customs and obtain any required government approvals pertaining to use of the other Party's marks.

  • Quality Requirements Performance Indicator Heading Indicator (specific) Threshold Method of Measurement Frequency of monitoring Consequence of Breach QUALITY Patient Safety - Incidents I1 Number of incidents Adverse incidents include the following: clinical or non clinical adverse events that have potential to cause avoidable harm to a patient, including medical errors or adverse events related to medical devices or other equipment. Clinical or non- clinical accidents, accidental injuries to staff and members of the public, verbal, physical or psychological abuse or harassment, unusual or dangerous occurrences, damage to trust property, plant or equipment, fire or flood, security, theft or loss, near misses are identified as any event where under different circumstances significant injury or loss may have occurred Number of recorded incidents in the contract month Monthly Remedial Action Plan brought to Performance Meeting following breach; action under Module C Clause 32 if needed I2 Number of Sis Definition of SUI according to trust policy and national guidance Number of Serious Untoward Incidents reported in contract month Monthly Remedial Action Plan brought to Performance Meeting following breach; action under Module C Clause 32 if needed S1 Percentage of eligible staff received child safeguarding training at level 2 (as identified in LSCB training strategy) 95% Number received training/ Number of identified staff requiring training Monthly S2 Percentage of eligible staff received adult safeguarding awareness training at level 2 ( as identified in K&M Safeguarding Vulnerable Adults training strategy) 95% Number of staff trained/ Number of identified staff requiring training Monthly

  • Compliance with Regulations T, U and X Neither the Borrower nor any of its Restricted Subsidiaries is engaged principally or as one of its important activities in the business of extending credit for the purpose of purchasing or carrying, and neither the Borrower nor any of its Restricted Subsidiaries owns or presently intends to acquire, any “margin security” or “margin stock” (the “Margin Stock”) as defined in Regulations T, U, and X (12 C.F.R. Parts 220, 221 and 224) of the Board of Governors of the Federal Reserve System (the “Fed Regulations”) which would result in any violation of the Fed Regulations. None of the proceeds of the Loans will be used, directly or indirectly, for the purpose of purchasing or carrying any Margin Stock or for the purpose of reducing or retiring any Indebtedness which was originally incurred to purchase or carry Margin Stock or for any other purpose which might constitute this transaction a “purpose credit” within the meaning of said Regulations, in each case which would result in any violation of the Fed Regulations. The Borrower has not taken, caused or authorized to be taken, and will not take any action which might cause this Agreement to violate any Fed Regulation or any other regulation of the Board of Governors of the Federal Reserve System or to violate the Securities Exchange Act of 1934, in each case as now in effect or as the same may hereafter be in effect. If so requested by the Administrative Agent, the Borrower will furnish the Administrative Agent with (i) a statement or statements in conformity with the requirements of the applicable Federal Reserve Forms referred to in Regulation U of said Board of Governors and (ii) other documents evidencing its compliance with the margin regulations, reasonably requested by the Administrative Agent. Neither the making of the Loans nor the use of proceeds thereof will violate, or be inconsistent with, the provisions of any Fed Regulation. Following the application of the proceeds of each Loan and Letter of Credit, not more than twenty-five percent (25%) of the value of the assets (either of the Borrower only or of the Borrower and its Restricted Subsidiaries on a consolidated basis) subject to the provisions of Section 7.2 or Section 7.4 or subject to any similar restriction contained in any agreement or instrument between the Borrower and any Lender or any Affiliate of any Lender relating to Indebtedness subject to Section 8.1(k) will be “Margin Stock”.

  • Regulation M Compliance The Company has not, and to its knowledge no one acting on its behalf has, (i) taken, directly or indirectly, any action designed to cause or to result in the stabilization or manipulation of the price of any security of the Company to facilitate the sale or resale of any of the Securities, (ii) sold, bid for, purchased, or, paid any compensation for soliciting purchases of, any of the Securities, or (iii) paid or agreed to pay to any Person any compensation for soliciting another to purchase any other securities of the Company, other than, in the case of clauses (ii) and (iii), compensation paid to the Company’s placement agent in connection with the placement of the Securities.

Time is Money Join Law Insider Premium to draft better contracts faster.