1. S

    21 CFR 810 - Medical Device Recall Authority - Contract Manufacturing

    When a contract manufacturer produces a finished medical device for a customer/design owner, is one specific party expected to initiate the recall, or is it based on internal agreement between the design owner and the contract manufacturer? I work for on the contract manufacturing side and am...
  2. S

    Responsibilities between government owner and private subcontractor of a power plant seeking ISO 9001 certification

    Dear friends I have some questions regarding ISO 9001:2015, where there is a governmental body own a power planet station. The station is operated by a subcontractor who hires stuff and do all the operation and maintenance activities and submit report to the owner. The governmental body need...
  3. W

    Organizational Responsibility for Environmental Compliance of Products

    Hey everyone, I lead the Quality and Regulatory department for a medical device company and am interested in understanding what department or organizational umbrella environmental related product compliance (RoHS, REACH, Prop 65 etc) responsibilities generally fall under in other companies...
  4. A

    Who pays for correction and removal actions?

    Hello everyone, I am looking for information about who is responsible for (from a regulatory perspective) fixing an issue related to a recalled device? I cant find any statements in any regulations regarding cost responsibilities. Is there a way to decide when a manufacturer is responsible...
  5. M

    Where does our regulatory responsibility end?

    We have a good customer (let's call them ABC) that buys our medical device (software) and rebrands/relabels it for sale as a product with their name on it. They now want to sell our medical device in Mexico. This would not be an ABC-rebranded or relabeled version of our medical device, but...
  6. M

    Prescription Devices - Who is Responsible / Liable?

    Who is responsible for ensuring that devices designated prescription only are, in fact, used only under prescription conditions? I'd brought this up in a previous post regarding a number of discussions surrounding implications of a device designated as prescription only in the US, but the...
  7. S

    Pandora's box - OPENS

    There have been some shifts in responsibilities in the organization where I work, which has resulted in me taking over the Order Fulfilment complaints, as well as the Product Quality responsibilities. We've had 14 OF complaints in the last 13 months, so I figured it wouldn't add much to my...
  8. S

    Medical Device Manufacturer vs. Specification Developer

    Hello, US Company A is the MD device owner and holds the associate 510k & Company B out of the USA manufactures the Medical Device. Company A kits the devices with its accessories, packages, and labels. => Shall company A be considered Manufacturer or Spec Developer ?
  9. N

    Who shall manage PPAP process?

    Hi I sometimes wonder who shall manage a PPAP process and who is the process owner in a company? We have Quality dept as PPAP owner, but sometimes thinking isnt the owner of PPAP the production? Many companies has Q-dept that are collecting and creating all PPAP documents.. incl PSW is...
  10. M

    Manufacturer - Distributor (Importer) Relationships

    I could use some clarification as to the specific responsibilities of (foreign) Manufacturers and local distributors (importers). Specifically with respect to MDR (21 CFR 803) and complaint handling (21 CFR 820.198). A couple initial questions to help me better understand: First: Can the...
  11. E

    Defined Roles in Small Company

    I am working for a very small company. Roughly 30 employees with a two person management team. A potential customer performed a supplier audit that produced a number of findings. Basically, we were told we need to move towards iso compliance if we want their business. Knowing very little...
  12. supadrai

    Forced into Regulatory Affairs Role - Where do I begin?

    Hi Everyone, I'm new here and have so far found this forum to be amazing with some very detailed information that is difficult to find elsewhere. Seems like you have great members here, and I hope to be in a position to contribute also. I was hired by my current company to deal with a...
  13. B

    Labeling requirements for Servicing and Repairing Medical Devices

    Hi All, :bigwave: I was wondering what the labelling requirements are for servicing medical devices which were manufactured some years ago which may become slightly worn or illegible, or contain information on their labels which has since changed, such as manufacturer's address details for...
  14. Fender1

    Customer specified Item Defect Corrective Action Responsibility

    Earlier this year, our customer sent us a complaint related to a sub-assembly, that they specify we obtain and connect to the product that we produce for them. We are not design responsible for the sub-assembly or the product that we produce. Our customer specifies the sub-assembly manufacture...
  15. J

    Functional group / area responsible on a Control Plan

    Hi, I am studying in item "l functional group / area responsible" of general data of A2 element of control plan in Annex A of IATF16949 now. In AIAG at CP topic, it is not specified its meaning of this element so could you let me know what is? Thank you very much in advance.
  16. J

    Manufacturing Safety Wire Training and Certification - Who should train

    We need to initiate safety wire training and certification for both production workers and inspectors as required by our customer. The question raised was who should perform the training? I stated the since production actually performs the task, that the training be performed by production...
  17. Q

    Who does a QC (Quality Control) Auditor report to?

    This may sound like a dumb question, but I need a clear cut answer, preferable with a link to where it states this online please. We are are 3rd party logistics provider. We have QC auditors who audit different departments. Who do the auditors usually report to? What is the industry standard or...
  18. M

    Complaint Handling Responsibilities for a Design Partner - ISO 13485

    First, thank you all in advance for your help. I work for a company that helps design medical devices. Our customers are the legal manufacturers, and hold all the intellectual property. At the end of a particular project, our customer takes full ownership of the design. We have an ISO...
  19. Kronos147

    Quality Manager's Role in AS9100 Rev. D

    AS9100 Rev. D clause 0.2 introduces the seven management principles: − customer focus; − leadership; − engagement of people; − process approach; − improvement; − evidence-based decision making; − relationship management From my experience as a 3rd party auditor, the scope of the audit...
  20. N

    QA and only QA, or Jack of all Duties? Crossing Departmental Boundaries

    In my early training in the Quality field, one of my instructors stressed that we should always do QA/QC, and only QA/QC, else we find ourselves going down a path that ends to failing in your Quality duties. His theory was once you go down the road of doing something that another department...
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