ISO 13485 Sample Clauses

ISO 13485. Supplier will ensure, continuously throughout the Term and thereafter, as applicable, that Supplier and any authorized Subcontractors used by Supplier in the manufacture of Units will have current ISO 13485 certification, FDA registration and any other applicable certifications for the factories in which Units will be manufactured. If either Supplier or Supplier’s authorized Subcontractors no longer possess the ISO 13485 certification, FDA registration and any other applicable certifications for the factories in which Units will be manufactured, Supplier will notify Eargo in writing immediately. Supplier and any authorized Subcontractors will then have [***] from the date of such notice in which to be recertified by the applicable certifying body and furnish evidence of the same to Eargo.
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ISO 13485. 2003 The Supplier and Customer shall each maintain a Quality Management System (QMS) that conforms to the requirements of ISO 13485:2003. The Supplier shall resister the QMS with a registrar acceptable to the Customer. The Supplier shall provide a copy of the registration certificate to the Customer. Should the Supplier determine that a requirement of ISO 13485:2003 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 2.
ISO 13485. At all times during the Term, Bio-Techne covenants that it shall be certified to be in compliance with the ISO 13485:2016 Quality System Standards. The notified body that issues any certificate of compliance to Bio-Techne shall be a body that is authorized by FDA to conduct audits under the Medical Device Single Audit Program (MDSAP).
ISO 13485. Bio-Techne has been certified to be in compliance with the ISO 13485:2016 Quality System Standards by a notified body that FDA has authorized to conduct audits under the Medical Device Single Audit Program (MDSAP).

Related to ISO 13485

  • 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

  • Hardware and Software Requirements In order to access and retain Disclosures electronically, you must satisfy the following computer hardware and software requirements: access to the Internet; an email account and related software capable of receiving email through the Internet; a web browser which is SSL-compliant and supports secure sessions, and hardware capable of running this software.

  • Additional Regulatory Requirements Notwithstanding anything contained in this Agreement to the contrary, it is understood and agreed that the Bank (or any of its successors in interest) shall not be required to make any payment or take any action under this Agreement if:

  • Technical Requirements 2.7.4.1 The NID shall provide an accessible point of interconnection and shall maintain a connection to ground.

  • Xxxxxxx Xxxxxxx Restrictions/Market Abuse Laws The Participant acknowledges that, depending on his or her country, the broker’s country, or the country in which the Shares are listed, the Participant may be subject to xxxxxxx xxxxxxx restrictions and/or market abuse laws in applicable jurisdictions, which may affect his or her ability to accept, acquire, sell, or attempt to sell or otherwise dispose of Shares or rights to Shares (e.g., Special Retention Awards) or rights linked to the value of Shares, during such times as the Participant is considered to have “inside information” regarding the Company (as defined by applicable laws or regulations in the applicable jurisdictions, including the United States and the Participant’s country). Local xxxxxxx xxxxxxx laws and regulations may prohibit the cancellation or amendment of orders the Participant placed before possessing inside information. Furthermore, the Participant may be prohibited from (i) disclosing the inside information to any third party, including fellow employees (other than on a “need to know” basis) and (ii) “tipping” third parties or causing them to otherwise buy or sell securities. Any restrictions under these laws or regulations are separate from and in addition to any restrictions that may be imposed under any applicable Company xxxxxxx xxxxxxx policy. The Participant acknowledges that it is his or her responsibility to comply with any applicable restrictions, and the Participant should consult his or her personal advisor on this matter.

  • Clinical Data and Regulatory Compliance The preclinical tests and clinical trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, Registration Statement, the Pricing Disclosure Package or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with applicable laws, rules, regulations and policies of the Food and Drug Administration of the U.S. Department of Health and Human Services (the “FDA”) or any committee thereof or of any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are materially inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Pricing Disclosure Package or the Prospectus; for such studies that have been or are being conducted, the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by foreign government or drug or medical device regulatory agencies, or foreign health care facility Institutional Review Boards; and no investigational new drug application filed by or on behalf of the Company or any of its subsidiaries with the FDA has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign regulatory agency has commenced, or, to the knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay or suspend, any proposed or ongoing studies conducted or proposed to be conducted by or on behalf of the Company or any of its subsidiaries.

  • Environmental, Health and Safety Matters (a) The Company has complied and is in compliance with all Environmental, Health, and Safety Requirements.

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