Webownership should certainly be considered sufficient to satisfy the definition of ‘placed on the market’. As procedures may vary from company to company, the interpretation is left to the individual company to decide. Additional clarification may be provided by the European Commission in the revision of the Blue Guide. WebMar 3, 2016 · 4 Terms and definitions For the purposes of this guidance document, the terms and definitions in Act 737, the regulations under it and the following requirements apply: 4.1 Device history record (DHR) History records of one or many refurbished medical devices reflecting operations,
FDA requirements for Servicing and Refurbishment of …
WebRecall means a firm's removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g ... WebMar 31, 2024 · Word forms: refurbishes, refurbishing, refurbished. transitive verb. To refurbish a building or room means to clean it and decorate it and make it more attractive or better equipped. We have spent money on refurbishing the offices. Synonyms: renovate, restore, repair, clean up More Synonyms of refurbish. Collins COBUILD Advanced … kitchenaid cookware dishwasher safe
White Paper: Evaluating Whether Activities are Servicing or …
WebMar 22, 2024 · Register. 2. List all the devices you will work on. 3. Set up and maintain a QMS, including all of the actions needed for your organization under that QMS to be conforming. 4. If the devices you work on are radiation emitting, file the appropriate reports. Last edited by a moderator: Mar 25, 2015. M. WebMar 23, 2024 · According to Section 710(c) of FDARA, FDA differentiates the following terms: refurbishing, reconditioning, rebuilding, remarketing, repairing, remanufacturing, … WebPlacing on the market of fully refurbished medical devices Chapter: 2.1 Scope, field of application, explanation of terms Text: Definition of “manufacturer“: “manufacturer“ … kitchenaid cookware macy\u0027s