device master record (dmr)

  1. R

    DMR or Manufacturing Documentation - How detailed does the documentation have to be?

    Hello everyone, For those who have had experience assembling DMRs, with respect to manufacturing instructions, how detailed does the documentation have to be so as not to give away proprietary information. For example, in machine assembly drawings or a manufacturing process flow chart or...
  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. S

    DMR (Device Master Record) for Medical Device Software

    Do we necessarily have a DMR for Medical Device Software? What is listed in a software DMR? Thanks!
  4. Q

    Is a DHR enough to fulfill 13485:2016's Medical Device File requirement?

    We are a contract manufacturer and do not keep DHF's or DMR's on the products since we do not own the specifications. We do have DHR's, specific for each lot of parts. Is it acceptable to fulfill 4.2.3 Medical Device File?
  5. S

    Integrating a Contract Manufacturer's documentation into our Quality System

    Hi everyone, My company recently brought the manufacturing process in house from the contract manufacturer. In our DMR, I have noticed that there is a lot of documentation from the contract manufacturer including their quality plan and DHR templates. What I don't know is how the contract...
  6. S

    Quality Plan at a small Medical Device Company - Is the quality plan a DMR document

    Hi everyone, This has been such a helpful forum. I am planning to work on a quality plan at our small medical device company. Is the quality plan a DMR document? Where should it exist? Thank you very much. :thanx:
  7. M

    Merge Technical File, DMR, and Device File into a single document?

    Given that we market in the United States and in Europe, and maintain an EN ISO 13485:2016 quality system, we have the following documentation requirements for each project: A "Medical Device File" (as required by EN ISO 13485:2016, 4.2.3) A "Technical File/Design Dossier" (for CE Marking)...
  8. 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...
  9. S

    Device Master Records for a Contract Manufacturer

    In reading the DMR requirements, it is definitely the customer responsibility to prepare and maintain a DMR. But is a Contract Manufacturer required to prepare a DMR based on the manufacturing process and including all information relating to Customer Drawings, Specifications, List of SOPs...
  10. S

    DMR (Device Master Record) Management and Index questions

    We're a fast growing Medical Device company that markets different types of kits in multiple configurations. Haven't seen recent info on Device Master Record management so I have several questions: What is the most effective way to set up the DMR index to properly maintain? Should there be...
  11. U

    Document Revisions Required in DMR Index?

    Hello Covers! We are a small medical device firm. We are virtual, in that we own the design, registration, etc. but we contract all manufacturing, and perform lot release testing, document verification and final product release. Apart from lot release samples, we never actually see the product...
  12. D

    ISO 9001 Design Process Flow Chart

    Hi all. I'm attempting to verify the completeness of a design control procedure and identify the resulting documentation with regards to the requirements of ISO 9001. I'm a little more familiar with medical device design requirements, and I'm trying to follow the least burdensome approach by...
  13. J

    How does your organization store documents for Class I and Class II Medical Devices?

    Looking for thoughts on Class I and Class II docs (DHR, DMR): How is your organization storing these? Waterproof folders? Sprinkler-free room? Water-tight file cabinet, etc.?
  14. I

    Device Master Record Requirements for Component Manufacturer

    We recently had an ISO 13485 audit and was issued a non-conformance for not having a DMR. Do you need to have a DMR if you are only producing a component consisting of only one item? Any help would be appreciated.
  15. B

    DMR (Device Master Record) For Contract Manufacturers

    I work for a company in the US. We have a sister company in Ireland we are using as a contract manufacturer for some of our Class II devices. We own the design in the USA (i.e., we designed the device and maintain the DHF, DMR, 510(f), etc.), and the sister company in Ireland is ISO 13485...
  16. C

    Medical Device Product Registration, Product Family, Device Name

    Hello, My company sells medical devices through distributors in the EU, Japan and a few other countries. I want to ask for your advices and view of our problem. Our current product naming stucture is the following for ECG Holter devices without BP: Company name then XX-2H, XX-3H, XX-12H (the...
  17. C

    When to submit a 510(k)? After the DMR (Device Master Record) is finished?

    Hi all: Is there any regulation about how early to submit a 510(k)? for example, after the DMR finished? Thank you for any input.
  18. U

    What is a Medical Device "Master Item File"?

    Hello, First off, I am new to Quality Management so please be patient with me. We are a small medical device company and starting to build our Quality System. Along the line, I see that there is a need for a 'Master Item File'. To me, it sounds like it's a record of all the item we use in...
  19. J

    Contents of DMR (Device Master Record) when manufacturing is by 3rd party

    We are a medical device company in the US and I have been given the job of updating our Device Master Records. We are the specification holder, but the devices in question are manufactured, packaged and sterilized by a third party vendor. The devices are received into our company, inspected...
  20. A

    DMR (Device Master Record): What is meant by these words - Software Specifications?

    Hello all, I have a short question. You know, §820.181(a) describes device specifiactions. From my point of view everything is clear in this section - exept the term with "software specifiactions". What is meant by these words? What are "device software specifiactions" exactly - are they...
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