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 register 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

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