clinical trials and studies and investigations

  1. 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...
  2. B

    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.
  3. F

    China Clinical Trials Requirements

    Hello, Does anyone know what the requirements are for sending non-medical devices to for a clinical trial? Thanks
  4. 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...
  5. 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...
  6. 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
  7. 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
  8. 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...
  9. 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...
  10. 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...
  11. W

    PMCF (Post-Market Clinical Followup) vs PMCF studies

    Hello, I'm new here, I tried to find the answer to my question in the posts but unfortunately I didn't find it. I apologize in advance for my English. Is PMCF the same as PMCF studies? Everywhere I find a plan for PMCF studies that plans clinical trials. I am confused. Can I turn off this plan...
  12. N

    Substantial or non-substantial modification in clinical studies

    Hello! Can anyone tell me whether there is some guidance as to when to consider a modification to a clinical study protocol as substantial or non-substantial? Thank you!
  13. BreeJeong

    PMCF study plan is same to clinical investigation plan?

    Hi there!:bigwave: I'm getting a lot of help from here. Thank you, everybody! I am not good at English. so please understand my English mistake :) I have worked as a medical device RA only two years. CE TCF of an orthopaedic implant (Class IIb) have been auditing since June 2016 by a...
  14. M

    MDR Clinical Evaluation & investigation (SUMMARY of changes)

    Recently I have been reading the new MDR and assisted several webinars. This is my summary of changes. Hope it helps y'all! I would be grateful for your feedback and also if after reading you can think of: -any important implications for industry I have not listed -the answer to any of the 3...
  15. J

    MDR and Creative Clinical Evidence

    Hello all, This morning I watched a webinar which was about preparing for MDR. In the presentation, the speaker mentioned coming up with creative ideas to use for clinical evidence which would be less costly than clinical trials. She suggested possibly using focus groups, establishing a...
  16. L

    EU MDR CRO (Contract Research Organization) requirements for Clinical Investigations

    Hello, I am trying to understand MDR requirements for clinical investigations. But it is not clear to me whether a CRO located outside the Union can conduct clinical investigations in the Union (or outside the Union to comply with NB demands). In Article 62, paragraph (2), there is a...
  17. S

    Do subjects pay for a medical implant in PMCF study?

    Hi,:bigwave: I'm quite new to medical device industry, Our Organization is going to start a PMCF/PMS study in India and Europe as well. Since medical implants are very costly, do subjects need to pay for an implant? I have worked in a Pharmaceutical company where drugs are given to subjects...
  18. J

    Biologic Injectable Device Clinical Trial Packaging/Labeling/Artwork Guidelines

    I am trying to find guidelines regarding biologic injectable device clinical trial packaging/artwork/labeling for the US. I can see FDA guidelines for commercialised product but not for clinical trials. Can anyone help me? All the best, jmlbell
  19. I

    Adverse Event Reported during Non-Approved Indication Use

    One of our clients is using a device he purchased to us to perform a clinical trial outside our CE mark indications. He is the sponsor and the investigator, we are not involved in his activity at all. However he has reported us an adverse event (no SAE). This event is not related to the...
  20. R

    Background of Annex X section 1.1d of MDD 93/42/EEC

    Hi forum, Does any one know the background of Annex X section 1.1d of MDD 93/42/EEC? How will it happen?
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