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Search results for query: "GSPR checklist"

  1. planB

    EU MDR - Annex II 6.1 Pre-clinical and clinical data

    Cybel, you may want to present references to your data as part of your GSPR checklist. A test protocol should to a minimum contain scope and purpose of the planned test, description of samples and their justification (including sample size), description of test method and its justification...
  2. planB

    Appendix Z in Harmonised Standards?

    Cybel, a word of caution: MDD-harmonised standards may be outdated and superseded by newer state-of-the-art standard revisions. Under the MDR, you may want to conservatively cross-reference the latest ISO revision of standards in this case. One prominent example is state-of-the-art ISO...
  3. F

    MDR GSPR Checklist template

    Hi, I saw someone asked for this before, but I am looking for a table/template for the MDR GSPR that is free. Thanks!
  4. A

    MDR GSPR Checklist wanted

    Does anyone have or will be willing to share a checklist document that includes the list of GSPR according to the MDR and a list of all the possible harmonised standards, common specifications or other documents that would apply and if possible the methods used to demonstrate conformity with...
  5. M

    MDR - GSPR - Annex I - Chapter II

    What I understood (and subsequently documented a decision in my GSPR checklist) is that, this requirement is saying if you have done any biophysical simulation (something like Computational Modelling!) of your device by following any previously validated method! If so, then document the results.
  6. D

    Checklist for MDD to MDR gap analysis

    Do you by any chance have a GAP Assessment Checklist. Thanks in advance.
  7. V

    MDR - Is a formal GSPR Procedure required?

    I have level 2 document named "Compilation of Technical File" where all necessary documents and its contents are summarized in a table. GSPR checklist form is referred here.
  8. J

    MDR - Is a formal GSPR Procedure required?

    I've created a system-wide GSPR checklist which identifies where each clause is managed in our system, and included a significant section of the GSPR in product family technical files. This should help us quickly identify how we comply if asked (by our responsible authority moreso than 13485...
  9. R

    Checklist for MDD to MDR gap analysis

    Hi all, attached you can find full GSPR checklist MDR. If you have any questions/comments or would like to recieve any other checklist in relation to MDR, let me know.
  10. T

    IVDR and MDR ANNEX I Requirements Template

    I'm not sure why you're not able to take your existing Essential Requirements Checklist and paste in the requirements from the Annex of the Regulations to create a GSPR checklist? This seems like an easy enough thing to do. If you're just after one that you can use from scratch, then I don't...
  11. M

    Checklist for MDD to MDR gap analysis

    Can someone share their extensive EU MDR - GSPR checklist? Thanks!
  12. J

    Checklist for MDD to MDR gap analysis

    Apologies! Just looked at it. Annex I defines the GSPR “General Safety and Performance Requirements” requirements to establishes conformity with MDR.
  13. J

    Checklist for MDD to MDR gap analysis

    Here's a sample checklist. Can someone explain me the difference between MDR and GSPR checklist? Is it the same? Thanks, jnks
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