Technical Files definition

Technical Files means all design history files, device master records, device history records, validations, clinical data related exclusively to the Products, technical documentation (including design dossier), complaint files, records of adverse events, reports of adverse events, corrections or recalls, and quality management documents related to the Products.
View Source
Technical Files means, with respect to the Products, a tangible copy of all the product registration applications, including all supporting files, writings, data, studies and reports compiled for the granting of the Product Registrations.
View Source
Technical Files means documentation required to assess conformity of the medical device with the regulations.
View Source

Examples of Technical Files in a sentence

  • Following the expiration or the earlier termination of this Agreement, Admedus shall provide all such Technical Files to LeMaitre, as updated through the date of expiration or earlier termination.

  • Admedus shall maintain all Technical Files (as defined below) for those Products manufactured by Admedus in compliance with all applicable laws and regulations at its own expense for the term of this Agreement, including, without limitation, updating and maintaining all clinical evaluation reports for all Products to comply with the requirements of MEDDEV 2.7/1, revision 4 on a timely basis.

  • All the information on the asbestos risk is listed in the summary sheet of the Asbestos Technical Files.

  • The technical assistance specifications are detailed below: GRD – EMAPA San ▇▇▇▇▇▇: NIWS hired NGO Practical Action to elaborate the Technical Files for a natural infrastructure intervention project called, “Creation of protection services with natural infrastructure for the collection and conduction line of the water system of the ▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇ ▇▇▇▇▇ ▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇ and San ▇▇▇▇▇▇ Region”.

  • Assisting Corgenix in preparation of the Summary and Detail Technical Files.

  • ALCON shall own and maintain all regulatory applications, notifications, and dossiers with respect to the ALCON Finished Product (or any other ALCON product that results from use of the Product), including, without limitation, PMAs, 510(k)s, Technical Files and other marketing authorizations.

  • Except as may otherwise be required by applicable law or regulation, Admedus shall maintain all Technical Files (as defined below) for those Products manufactured by Admedus in compliance with all applicable laws and regulations at its own expense for the term of this Agreement, including, without limitation, updating and maintaining all clinical evaluation reports for all Products to comply with the requirements of MEDDEV 2.7/1, revision 4 on a timely basis.

  • Upon request by L▇▇▇▇▇▇▇, Admedus shall provide all such Technical Files to LeMaitre.

  • Additionally, support has been provided to the Piura watershed, specifically with technical-financial assistance for the design of 2 Technical Files (Pata-Uchupata Micro-watersheds in the El Faique district and Pusmalca Micro-watersheds in the Huarmaca district), whose articulation to the Plan RCC of the Piura watershed has been done with the ▇▇▇▇ Piura.

  • Number Ownership Items - IVDD 1 IVDD Certification 2 Labeling and language requirements per IVDD 3 Technical Files 4 Declaration of Conformity 5 Risk Analysis 6 Essential Requirements 7 Management of Notified Body review and approval 8 Legal Manufacturer Defined 9 Other The required Changes and Approval section is listed below: Changes and Approval # Initial approval and changes to OEM Quality Agreements require approval of both companies.


More Definitions of Technical Files

Technical Files means the documentation relating to the Products that contain information on the Products as required by the FDA, the HPFB or other Regulatory Authorities.
View Source
Technical Files means all design history files, device master records, device history records, validations, clinical data related exclusively to the Products, technical documentation (including design dossier), complaint files, records of adverse events, reports of adverse events, corrections or recalls, and quality management documents related to the Products. For the avoidance of doubt, Admedus shall remain legal manufacturer of the Products until such time as mutually agreed by the Parties unless otherwise required by applicable law or regulation. When LeMaitre files for CE certification under MDR, LeMaitre will identify LeMaitre as the legal manufacturer for purposes of such certification and assumes all responsibility as legal manufacturer in that territory regarding Products manufactured by LeMaitre. LeMaitre is solely responsible for sales of Products manufactured by Admedus in any relevant territory to CE certification after Admedus’s current CE mark registration for the Products lapses.”
View Source

Related to Technical Files

  • Personnel file means, for the purposes of Part III (8VAC20-90-60 et seq.), any and all memoranda, entries or other documents included in the teacher's file as maintained in the central school administration office or in any file regarding the teacher maintained within a school in which the teacher serves.

  • Technical Data means recorded information, regardless of the form or method of the recording, of a scientific or technical nature (including computer software documentation). The term does not include computer software or data incidental to contract administration, such as financial and/or management information.

  • APIs means SAP application programming interface and accompanying or related Documentation, source code, tools, executable applications, libraries, subroutines, widgets and other materials made available by SAP or through SAP tools or SAP Software Development Kit (and all derivative works or modifications thereof) to Provider that allow Provider to integrate the Provider Service with the Cloud Service, including any access code, authentication keys or similar mechanisms to enable access of the APIs.

  • Study Materials means all the materials and information created for the Study, or required to be submitted to the Sponsor including all data, results, Biological Samples, Case Report Forms (or their equivalent) in whatever form held, conclusions, discoveries, inventions, know-how and the like, whether patentable or not, relating to the Study, which are discovered or developed as a result of the Study, but excluding the Institution’s ordinary patient records.

  • Deliverables means the goods, services, and work product, including all reports and project documentation, required to be provided by Grantee to the System Agency.