Miri­am Schuh

Exper­ti­se

• Medi­cal device law and medi­cal law
• eHe­alth and mHe­alth: Advi­sing deve­lo­p­ment ser­vice pro­vi­ders and manu­fac­tu­r­ers on the qua­li­fi­ca­ti­on and clas­si­fi­ca­ti­on of soft­ware as a medi­cal device, in par­ti­cu­lar with regard to medi­cal apps and advi­sing manu­fac­tu­r­ers on the appli­ca­ti­on pro­ce­du­re for the DiGA directory
• Arti­fi­ci­al intel­li­gence in medi­cal devices
• Con­tract law along the enti­re sup­p­ly chain
• Com­mu­ni­ca­ti­on with aut­ho­ri­ties and litigation

Care­er

• Stu­di­ed law in Saarbruecken
• Work­ed at the Ocha­no­mi­zu Law Office, Tokyo
• Work­ed in the legal depart­ment of West LB Secu­ri­ties Ltd., Tokyo
• Free­lan­cer in the are­as of HR sup­port, HR con­sul­ting and employee development
• Att­or­ney at reuschlaw
• Com­ple­ted cour­se for att­or­neys spe­cia­li­zing in medi­cal law

Cur­rent pro­jects (extra­ct)

• Sup­port­ing eco­no­mic ope­ra­tors in the health­ca­re sec­tor in the imple­men­ta­ti­on of the regu­la­to­ry requi­re­ments of MDR and IVDR
• Sup­port­ing manu­fac­tu­r­ers of medi­cal devices, inclu­ding IVDs, in con­tract manage­ment with cri­ti­cal sup­pli­ers and dis­tri­bu­tors, inclu­ding the nego­tia­ti­on of qua­li­ty assu­rance agreements
• Sup­port­ing manu­fac­tu­r­ers of medi­cal devices, inclu­ding IVDs, in the (re)structuring of vigi­lan­ce pro­ces­ses, in par­ti­cu­lar for the effi­ci­ent imple­men­ta­ti­on of mar­ket mea­su­res in coope­ra­ti­on with dis­tri­bu­tors and inter­na­tio­nal regu­la­to­ry authorities