medical devices

  1. Marcelo Antunes

    Informational NYT editorial – 80,000 Deaths. 2 Million Injuries. It’s Time for a Reckoning on Medical Devices.

    May be paywalled – 80,000 Deaths. 2 Million Injuries. It’s Time for a Reckoning on Medical Devices. Posted at Marcelo's Medicaldevice.expert website... You may comment and discuss in this discussion thread.
  2. Marcelo Antunes

    Informational EU – Medicinal products and medical devices: Coordinated approach in case of a withdrawal of the United Kingdom from the Union without a deal

    Medicinal products and medical devices: Coordinated approach in case of a withdrawal of the United Kingdom from the Union without a deal Posted at Marcelo's Medicaldevice.expert website... You may comment and discuss in this discussion thread.
  3. K

    Change of Existing Medical Devices and 510(k)

    Hi We are manufacturer of Medical X-Ray equipment and already approved by FDA for our one of product. We want to know about the changes for which 510(K) re-submission is required. for example , If we are adding any alternate model of X-Ray tube and Flat panel detector (Image capturing device)...
  4. Marcelo Antunes

    Informational TGA – Action Plan for Medical Devices

    Action Plan for Medical Devices Posted at Marcelo's Medicaldevice.expert website... You may comment and discuss in this discussion thread.
  5. Marcelo Antunes

    Informational USFDA – Review framework for artificial intelligence-based medical devices

    Statement from FDA Commissioner Scott Gottlieb, M.D. on steps toward a new, tailored review framework for artificial intelligence-based medical devices Artificial Intelligence and Machine Learning in Software as a Medical Device Proposed Regulatory Framework for Modifications to Artificial...
  6. Marcelo Antunes

    Informational COCIR Position Paper Harmonisation of Standards for Medical Devices

    COCIR Position Paper – Harmonisation of Standards for Medical Devices Posted at Marcelo's Medicaldevice.expert website... You may comment and discuss in this discussion thread.
  7. Ajit Basrur

    How do I label this commercial product ready for clinical study?

    We have a commercial product that will be supplemented with features that will eventually make the final product fall under a medical device and requiring clinical trials. How do I label this commercial product ready for clinical study - I presume the product name definitely has to be removed to...
  8. D

    The Status of ROHS for Medical Devices - April 2019

    Hi, Can any one resolve my queries as below 1. Whether ROHS 2 is made obsolete. 2. Whether ROHS 3 got released 3. Whether all the requirements of ROHs 1 & 2 or incorporate in ROHs 3? 4. As a medical device manufacturer which ROHS rev I need to show compliance against EU MDR? need clarification...
  9. Marcelo Antunes

    Informational COCIR paper – Advancing Cybersecurity Of Health And Digital Technologies

    ADVANCING CYBERSECURITY OF HEALTH AND DIGITAL TECHNOLOGIES Posted at Marcelo's Medicaldevice.expert website... You may comment and discuss in this discussion thread.
  10. S

    Medical Device - Change / Variations to a Medical Device

    Hi, I was wondering if someone could assist, we specialise in pharmaceutical products and our company recently acquired another company who also manufactures medical devices. If we wanted to make a minor or major change to medical device, is there a variation procedure or submission to follow...
  11. J

    Medical Device re-classification and marketing

    My company has decided to reclassify a device from class 1 to class 2. This was a decision made by us and no regulatory authority. My question is as we submit for the reclassification can we continue to market the device? Nothing about the device is changing besides the classification. Can we...
  12. W

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

    Question? Is it required to stamp hard copy DHR's "obsolete"
  13. 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...
  14. 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...
  15. 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...
  16. 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.
  17. 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,
  18. 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!
  19. 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...
  20. 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...
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