clinical trials and studies and investigations

  1. Marc

    European universities dismal at reporting results of clinical trials - 2019

    From European universities dismal at reporting results of clinical trials Many of Europe's major research universities are ignoring rules that require them to make public the results of clinical trials. A report published on 30 April found that the results of only 162 of 940 clinical trials...
  2. T

    Medical device Clinical trial exemption list

    Hello, Since CFDA's website upgrade to new NMPA structure, all download links have disappeared. I am searching for the official and latest documents from institutionnal sites: NMPA, CFDA... catalogue of medical devices exempted from clinical trials (I Know there are 2 of such files, word...
  3. 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...
  4. Marcelo Antunes

    Informational USFDA draft guidance – A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry

    A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry Continue reading at Marcelo's Medicaldevice.expert website... You may also comment and discuss in this discussion thread.
  5. M

    What is required to run human clinical trials in France

    I may provide QMS consulting for a startup medical device customer in France. We are working on developing a QMS while planning out a timeline and regulatory pathway. This may seem a simple question that I could determine myself by looking closely at the new EU MDR regulations, but can anyone...
  6. Marcelo Antunes

    Informational Microsoft Built a Bot to Match Patients to Clinical Trials

    Microsoft Built a Bot to Match Patients to Clinical Trials Continue reading at Marcelo's Medicaldevice.expert website... You may also comment and discuss in this discussion thread.
  7. Marcelo Antunes

    Informational USFDA Final Rule – Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices

    Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices Continue reading at Marcelo's Medicaldevice.expert website... You may also comment and discuss in this discussion thread.
  8. Marcelo Antunes

    Medical Device News TGA Consultation: Good Clinical Practice Inspections Program

    TGA Consultation: Good Clinical Practice Inspections Program Continue reading...
  9. Marcelo Antunes

    Pharmaceuticals News UK – Further guidance note on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal

    Further guidance note on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal Continue reading...
  10. 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...
  11. R

    Sample size for clinical validation/investigation

    Hi There, A new question for the cove : Where can we find guidance or rules to define the exact number of patients to be enrolled in a clinical validation or investigation ? MDR, MedDev, GHTF doc, EN14155, all documents says we should provide justification for the sample size. Ok, it makes...
  12. S

    Clinical Studies - Premarket Submission Requirements

    Hi everyone, I am new to clinical studies. My question is for a premarket submission, do you need the result of pivotal studies to apply for a class III/IV licence? Are results of feasibility studies sufficient? Thanks.
  13. F

    China Clinical Trials Requirements

    Hello, Does anyone know what the requirements are for sending non-medical devices to for a clinical trial? Thanks
  14. L

    Traditional 510(K) - Software - Clinical testing?

    Hello Everyone, I am very new in FDA processes. I would like to submit a traditional 510k to our software (almost the same as syngo VD11). We already have a CE mark, so we have a ton of documents, sometimes I don't understand the differences between the two system. Electromagnetic...
  15. F

    China Device Assisted Technology Clinical Trial

    Does anyone know if clinical trials involving device assisted technology (existing drug available and new device not available in China) requires registration/approval with the SMRA? I am aware that new drugs or new versions of drugs, both manufactured in China and being imported which are...
  16. S

    ITA (Investigational Testing Authorization) for Clinical Feasibility Study

    Hi, We are looking to conduct a feasibility study that will require an ITA. The study is small enough that we can manage it ourselves. Would this require that we setup an REB internally? TCPS 2 seems to be directed more towards universities and research institutions. Thanks
  17. R

    Clinical Trial to sell in the EU - Necessary or Not?

    Hi all, My company have a class III unique product, currently sold around 10,000 products in the USA. With this sort of PMS data am I still required to do a clinical study to sell in the EU? Hoping someone can help
  18. H

    Clinical investigation - Role of Notified Body (NB)

    Hello I am working towards CE marking of Class IIb device under the new IVDR, and am wondering what the role of the NB is during the clinical investigation/trial stage as part of the CE marking process. Obviously our competent authority will be notified and cleared to perform the...
  19. P

    ISO 14155 GAP analysis

    I have a Corrective Action from a NB Technical File review that has me pretty stumped. The trial was conducted in 2007 but the results of PMS or PMCF processes does not included and the manufacturer claim the trial was conducted according to EN ISO 14155:2011 but GAP analysis or justification...
  20. R

    Essential Performance of Mechanical Device?

    Looking for opinions on this question: I have a prototype where all the intended use is provided via an approved mechanical device (no electronics). We've added electronics to the device to capture usage data for a clinical study. The electronics do not contribute to the intended use, and...
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