device history record (dhr)

  1. R

    In this type of Legal Manufacturer-CMO arrangement, what happens to the DHR?

    Hello everyone. A manufacturer has contracted with an overseas CMO that will produce part of the device. Meanwhile, the manufacturer itself will also produce the other part of the device. However, the final packaging arrangement is interesting. For devices sold in the part of the world where the...
  2. S

    Foreign Manufacturer and DMR - Who keeps the DMR (Device Master Record)?

    Hi, If a company has an overseas manufacturer who receives all the DMR specifications from the parent company, who keeps the DMR? During an audit of the legal manufacturer, shouldn't the legal manufacturer have access to the DMR records? Thank you. How does the logistics work?
  3. C

    Serialization at Final Quality Check

    The company I work for is implementing a new line with fully electronic traveler/device history record. The system is 100% validated. However, there is discussion of programming it to assign the serial number to the device at the final inspection check. The argument being that this is done...
  4. V

    What is required in terms of the DHR, DMR, DHF?

    I work for a medical device organization and I am having just slight difficulty in making sure I am following the correct procedure regarding DHF, DMR, and DHR's. Our organization currently has a lot of products, some we manufacturer, some we import into the US, some we distribute, what is...
  5. J

    Electronic Device History Record (eDHR) Software Recommendations

    Is anyone using Part 11 compliant computer software for DHR generation? If yes, what? Would you recommend it? Why or why not? Our current system is paper-based and we have issues with incomplete or incorrect entries. We are interested in software where the information is entered, approved...
  6. K

    What technical documents need to be maintained for "manufactured for" items

    We currently sell a class I 510K exempt item which is registered and listed with the FDA and us as a distributor of said item are listed as repackager/relabeler. On the box our brand name is listed along with our part number, the manufacturer's CE and notified body and a manufactured by symbol...
  7. C

    Are DHR and Design Dossier synonymous?

    Sorry, this is not really a reply to that post, but I do not know how to start a new thread, So here goes......Is DHR and Design Dossier synonymous? Is this the document that is being referred to in EC design-examination certificate where it says that the ' design of the product was assessed and...
  8. S

    Requirement(s) for Fireproof Cabinets for Storing Batch Records

    I have heard that batch records shall be stored in fireproof cabinets - where do I get that reference ?
  9. G

    Could I destroy my DHR hard copy after 2 years after pdf'ing them ?

    I'm starting to convert DHR hard copies into PDF files to store them in our EDMS, I want to know if there is any regulation out there to dictate what to do with the hard copies, can I destroy them? should I keep them?. I know the 21 CFR part 820.180(b) talks about records retention for a period...
  10. S

    How is the "Date of Manufacture" determined ?

    Hello, I need your help again - we make components and finished devices and am trying to come up with a harmonized procedure on determining the "Date of Manufacture" and understanding "Batch" concept. We mold the components and make finished devices using Resin and Colorants. Typically the...
  11. renenatasha

    Usage of web articles in DHF (Design History File)

    Good day! :bigwave: I've a question concerning DHF. I'd like to know if web articles (such as Wikipedia) can be used as part of the Design Output's evidence in the DHF. :confused: For instance, my Design Input requirement says that sterilization process (EtO) should have minimal adverse...
  12. Q

    Device History Records Maintenance - Discontinued the use of the Product

    Curious as to how other Quality Managers maintain their Device History Records when customers state that they have discontinued the use of the product. Is there anyone willing to share briefly their process? I'm thinking that a letter to file or copy of the email from the customer stating that...
  13. R

    Who owns the DHR (Device History Record) for the Medical Device?

    Let me start by saying my company is a medical device manufacturer. We are also not the manufacture of record (our company name does not appear on the product). Here is the situation... We generate a DHR for each medical device we build. In the DHR are acceptance test records, travelers (or...
  14. E

    Traceability Requirements for Medical Device History Records (DHR's)

    Hi there, I'm just looking for a regulation that governs tracebility for medical devices. Specifically my question is: Is it ok to use 2 lots of a component in a sub-assembly Lot History Record. In other words mix componentsbut record both lots numbers. This would mean should you need to trace...
  15. R

    How to Handle 'Scrap and Replace' of Non-Conforming Products

    First let me say we are a ISO 13485 certified medical device company. I was wondering how others handle simple "scrap and replace" of non-conforming parts during the assembly process. As of this time our procedure reads that every reject needs a In-Process non-conforming items form attached...
  16. P

    What is to be documented to fulfill the requirements of ?820.65 Traceability?

    What is to be documented to fulfill the requirements of §820.65 Traceability? Hello, I work in a company which is registered by the FDA, and produces class III implants. We are a supplier and not the distributer. Right now we have a internal discussion, what must to be documented within the...
  17. M

    Medical Device Re-Labeling question - Customer has modified the labels

    :confused: I'm not quite sure where to post this. Hope this is acceptable. We package and label (all levels) a product for a customer then send product for sterilization. Product is then shipped from sterilizer to customer. However, customer has modified the labels (added a new CE mark) and...
  18. T

    Device Master Record For Medical Device Accessories

    Greetings All -- I have a question about the design master record where it specifically applies to accessories. As I read the FDA Guidance Document Section 8 -- I understand all devices need to have a DMR. However, it's the accessories that have me a bit confused. It says that if the...
  19. N

    Control of Medical Device DHF (Device History File)

    How any factory control the DHF? Keep the original Document in DHF or not? I think should be keep the control copy in DHF and keep original in document control center Please advice Tapapin
  20. E

    Should Product Website Content be treated as Labeling?

    Dear covers, I have a dilema regarding the applicable controls over the content of a product website. Reading the FDA Guidance on "Labeling", published in August 1989 (text quoted below in italics), and the "Device Labeling" website from the FDA "Device Advice" site, I understand that the...
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