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  • Specialty – Medical Device and Regulatory Affairs (DMAR)

    The UTC Master’s degree- DMAR has been devi­sed accor­ding to the new Euro­pean regu­la­tions on medi­cal devices (MDs) and concerns a new and regu­la­ted pro­fes­sion – head of ‘com­pliance, qua­li­ty and stan­dar­di­sa­tion’ for MD desi­gners, manu­fac­tu­rers or ope­ra­tors. This UTC Master’s degree pro­gramme address the key issues that relate to the patients’ safe­ty and the trai­ning will pro­vide actors who will be in a posi­tion to inte­grate the impor­tance of bio­me­di­cal tech­no­lo­gies whil­st ensu­ring appli­ca­tion of new pro­vi­sions of an evol­ving inter­na­tio­nal regu­la­to­ry scene.

    Pedagogy

    UTC – and espe­cial­ly note­wor­thy its Depart­ment of Bio-engi­nee­ring – was and still is a pio­neer and ranks among the lea­ders in France in terms of bio­me­di­cal work and qua­li­ty assess­ment (QA). The UTC Master's degree – DMAR relies on the plu­ri­dis­ci­pli­na­ri­ty of its tea­ching teams to pro­vide know­ledge and know-that relate to pro­cesses that ensure safe­ty and regu­la­to­ry com­pliance of medi­cal devices (MD).

    Pro­ject-orien­ted work­shops and case stu­dies allow the stu­dents to deve­lop apti­tudes and skills nee­ded for health-rela­ted regu­la­to­ry professions.

    A consi­de­rable frac­tion of course time is given over to guest lec­tures, deli­ve­red by both health sec­tor and indus­trial specialists.

    Professional openings

    To be in a posi­tion to:

    • mas­ter Euro­pean and inter­na­tio­nal regu­la­tions for Medi­cal Devices (MD);
    • gua­ran­tee qua­li­ty and safe­ty of medi­cal devices in full com­pliance with regu­la­tion throu­ghout the life cycle of the MDs;
    • ensure the inter­face bet­ween the various bio­me­di­cal com­pa­ny units to gua­ran­tee satis­fac­to­ry com­pliance of all its pro­ducts and processes;
    • mas­ter inter­nal and exter­nal audit/inspection operations.

    Contact and documentation

    Contact

    Res­pon­sable mas­ter
    San­drine Moran­dat
     +33 (0)3 44 23 44 23

    Contact

    Res­pon­sable de la men­tion
    Jean-Mat­thieu Prot
     +33 (0)3 44 23 43 99

    Contact

    Secré­ta­riat
    Fran­çoise Meresse
     +33 (0)3 44 23 79 53

    Contact

    For­ma­tion conti­nue
    Accueil
     +33 (0)3 44 23 46 29

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