ISO 13485 Clause Samples
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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.
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).
ISO 13485. Supplier shall maintain during the Term ISO 13485 Certification, applicable to the Facility.