medical devices

  1. W

    Is it required to stamp obsolete hard copy DHR's "obsolete"?

    Question? Is it required to stamp hard copy DHR's "obsolete"
  2. A

    System for Compliance Management (Medical Device)

    Dear all, I am looking for a list of robust compliance management systems to be used for medical devices. Something that can help addressing "must have" documentation/processess for a specific device profile. I found bsi Compliance Navigator and Greenlight Guru and I was wondering if...
  3. K

    How to define Expected life service life of medical device

    As we manufacturing the Medical device class IIb having Expected service life of 10 years. We are trying to justify the class on the basis of critical components include a justification for repairable parts as some of these components have life of 7 years.Its a long discussion with Notify body...
  4. Ed Panek

    Moving from Contract Manufacturing to Production In-House

    We use an ISO 13485:2016 manufacturing house to make our med device. Its a class 2 FDA 510 cleared and CE marked. We do not offer service or installation on our scope We are adding production. Is there a good checklist of objectives to allow me to communicate to our BoD what this change entails...
  5. Marcelo Antunes

    Informational TGA Consultation: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices

    Consultation: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices Continue reading at Marcelo's .expert website... You may also comment and discuss in this discussion thread.
  6. S

    UDI (Unique Device Identification) Requirements for Remanufactured devices

    Has any one extended UDI requirements for a remanufactured medical device - I was basically interested on how to define a process for a previous UDI over the remanufactured UDI? Thank you,
  7. T

    Change to Country of Origin on Medical Device Labeling

    Would a change in country of origin require notification to any of the MDSAP jurisdictions and/or the EU? The change has been approved by CBP, but didn't know if this labeling updating would require further notification since there is no safety-related update. Thanks!
  8. J

    Referencing Medical Device in FDA records - Package contains several other components

    Hi Everyone, I just came across this information and I am trying to find if there is any FDA guidance that explains this concept? so my current company is selling a class IIa device in package form, the package contains several other components that are manufactured by our clients. Our client...
  9. R

    Deciding if a medical device shall be supplied sterile or not

    Has anyone got a good rationale, a decision tree or a list of questions that could be used to help DnD engineers to decide if a medical device shall be supplied sterile or not ? I'm aware of the Spaulding classification, but it's more applied for retreating/reuse of MD. Here the point is, as a...
  10. 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...
  11. Marcelo Antunes

    Informational MDDI - It’s Time to Meet the Users of Medical Devices

    Interesting read on MDDI about empathy and co-creation in medical device design focusing in users and patients – It’s Time to Meet the Users of Medical Devices Continue reading...
  12. J

    What are a Taiwanese Medical device subcontractor's legal responsibilities with Taiwan regulations?

    Would anyone be able to provide guidance with the following case, please? A medical device is marketed in EU & US, with a EU company as legal manufacturer. This medical device is made with a Taiwanese subcontractor. However, the medical device is not placed on the Taiwanese market. Does the EU...
  13. E

    Ethylene Oxide Sterilization Validation-Reference Load

    Hello! My company is about to run an EtO sterilization validation on medical devices. We were told that our reference load, or dunnage load, needed to be filled with all products that represent the worst case load and that these products will be scrap. For a small company like us, this is just...
  14. Marcelo Antunes

    Medical Device News CDRH Research Programs – VICTRE: Virtual Imaging Clinical Trials for Regulatory Evaluation

    Interesting findings – “results of the computer-simulated VICTRE trial are consistent with the comparative trial using human subjects and human image interpreters. While further research is needed to assess the generalizability of the findings, the work reported in this article provides evidence...
  15. Leandro

    Need to register Medical Devices in Canada (FDA, HC, CMDCAS...)

    Hi! We're a company about to bring operations to Canada and we're in need to register our products - Class III prosthesis (in titanium). Also, there's the need to find a Contract Manufacturer to produce for us locally. Looking forward to hearing from you.
  16. M

    Include IFU in Class II Medical Device Marketing Brochure?

    Hi, We have written a 510(k) for a class 2 medical device and submitted the Instructions for Use and the Brochure. The FDA feedback we receive is: Indications for Use (IFU) are not clearly stated in promotional material for the devices. On page 108 (Brochure), it indicates that “The device...
  17. S

    Design Control for Class I Medical Devices

    While FDA design control regulation applies to all Class II and Class III devices, and also some Class I devices (with automated software and six devices), all other Class I devices are exempt from design controls. I would like to know how manufacturers of the design control exempt Class I...
  18. S

    Medical Device Cybersecurity Risk Management File

    Hi everyone, How does a company construct a matrix showing cybersecurity risks, if they do not result in patient harm, just data loss, but no patient is physically harmed. Thanks!
  19. S

    Is Lot Number required in addition to UDI serial number?

    We had a very interesting discussion this morning where the team was split in use of both Lot Numbers and UDI serial numbers. We will be having a new Class II medical device where each of the units (these are small units and not huge capital equipment) will have a UDI serial number. These units...
  20. Q

    ISO13485:2016 4.2.4 Control Of Documents - Lifetime of the Medical Device

    The last paragraph of this clause indicates "documents to which medical devices have been manufactured and tested are available for at least the lifetime of the medical device as defined by the organization..." which appears to be setting a bar. It goes on: "but not less than the retention...
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