medical devices

  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. 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...
  3. 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...
  4. 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...
  5. 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...
  6. 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.
  7. 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...
  8. 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...
  9. 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!
  10. 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...
  11. 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...
  12. T

    Change control and configuration management - When to create a new model/part number?

    Having a "discussion" amongst product development teams....when making a change to a current product (add a feature, minor design changes, etc.), when is it necessary (or best practice) to change the associated model number of the product as well? What criteria do you consider in your process...
  13. L

    Medtech regulation under scrutiny

    I haven't had the time yet to read through the articles published by ICIJ here International Consortium of Investigative Journalists - ICIJ , but I'm aiming to read through them to the weekend. But has anyone here read through them, or have peopled followed the news stories that ICIJ have...
  14. M

    What is Environmental intelligence specific to IVDs or Medical devices?

    Hello Team, What is Environmental intelligence specific to IVDs or Medical devices? Regards, Mallappa
  15. Ajit Basrur

    Medical Device News Medical Device Enforcement and Quality Report

    Good read: 1. The FDA has increased its oversight through additional device inspections 2. The FDA has taken a targeted, risk-based enforcement approach to address specific...
  16. Sidney Vianna

    Medical Device News International exposé of the harm caused by poorly tested medical devices.

    I receive updates from the ICIJ - The International Consortium of Investigative Journalists - a serious entity, in my estimation. The last email I received from them forewarns us that on Sunday, November 25th, 2018, they will release an exposé of the harm caused internationally by poorly-tested...
  17. TechnicalGuy

    Information regarding Nanomaterials in Medical Devices

    Hi Covers, Was hoping someone would be able to point me in the direction for information regarding nanomaterials in medical devices. What is the current legislation under the MDD? What is it in the MDR? What additional information is needed when a device incorporates a nanomaterial and where is...
  18. S

    When medical devices are sold domestically, can they be sold in Puerto Rico?

    I know the answer is a "Yes" but just wanted to confirm that when medical devices are sold domestically, that includes Puerto Rico as well, and that no additional approvals are required to sell a medical device in Puerto Rico? Thank you!
  19. E

    CB scheme applicability for battery powered medical devices

    Can anyone clear up a problem for me - looking at potential CB scheme certification for medical devices that are battery powered, but hearing that not applicable. Only those devices that use a medical power supply (AC to DC) require the CB cert, for the PSU only, and that needs to come from the...
  20. Marcelo Antunes

    Medical Device News BSI achieves Designation for its Netherlands Medical Devices Notified Body

    BSI achieves Designation for its Netherlands Medical Devices Notified Body BSI achieves Designation for its Netherlands Medical Devices Notified Body | BSI Group
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