Regulatory

Regulatory Affairs

We help you to devel­op an effec­tive reg­u­la­to­ry strat­e­gy for Europe, Cana­da and US mar­ket clear­ance. We focus on a short prod­uct devel­op­ment cycle, and deter­mine the require­ments for the Qual­i­ty Sys­tems of med­ical devices. In order to short­en the prod­uct devel­op­ment cycle, med­ical device man­u­fac­tur­ers need to iden­ti­fy as ear­ly as pos­si­ble the world-wide reg­u­la­to­ry require­ments for new or mod­i­fied prod­ucts. Until glob­al har­mo­niza­tion is reached, it is impor­tant to devel­op sup­port­ing doc­u­ments which are in com­pli­ance with Euro­pean, Cana­di­an and US require­ments for prod­uct sub­mis­sions. VISAMED can assist you in:

  • Train­ing on Reg­u­la­to­ry affairs
  • Reg­is­ter exist­ing Med­ical Devices with a UDI in the GUDID data­base
  • Devel­op­ing an effec­tive reg­u­la­to­ry strat­e­gy for Europe, Cana­da and US mar­ket clear­ance
  • Deter­min­ing the applic­a­bil­i­ty of the Euro­pean, Cana­di­an and US requirements/guidelines/standards
  • Deter­min­ing the Euro­pean and US Qual­i­ty Sys­tems require­ments
Europe

To receive in a time­ly man­ner the mar­ket clear­ance in Europe, VISAMED sup­ports you in the fol­low­ing activ­i­ties:

  • Strate­gic review and plan­ning to achieve device CE mark­ing
  • Device clas­si­fi­ca­tion
  • Con­for­mi­ty assess­ment pro­ce­dures
  • Noti­fied body selec­tion and coor­di­na­tion
  • Pre-assess­ment cer­ti­fi­ca­tion review audit
  • Tech­ni­cal file/dossier prepa­ra­tion
  • Essen­tial require­ments
  • Clin­i­cal eval­u­a­tion: Lit­er­a­ture research and analy­sis to sup­port prod­uct safe­ty and effi­ca­cy
  • Risk analy­sis and risk man­age­ment
  • Label­ing
  • Trans­la­tion of tech­ni­cal doc­u­men­ta­tion includ­ing label­ing
  • Com­pli­ance with post-mar­ket sur­veil­lance require­ments
Canada

To receive in a time­ly man­ner the mar­ket clear­ance in Cana­da, VISAMED sup­ports you in the fol­low­ing activ­i­ties:

  • Strate­gic review and plan­ning to archieve Cana­di­an med­ical device license clear­ance
  • Device clas­si­fi­ca­tion
  • Con­for­mi­ty assess­ment and stan­dard iden­ti­fi­ca­tion
  • Label­ing Cre­ation
  • Prepa­ra­tion of med­ical device license appli­ca­tions
  • Com­pli­ance with post-mar­ket sur­veil­lance require­ments
  • VISAMED can be your Autho­rized Rep­re­sen­ta­tive in Europe
USA

VISAMED as a Euro­pean based con­sult­ing firm can pro­vide local assis­tance to Euro­pean med­ical devices man­u­fac­tur­ers regard­ing US prod­uct sub­mis­sion require­ments espe­cial­ly for com­plex devices and devices con­tain­ing soft­ware. VISAMED sup­ports you in the fol­low­ing activ­i­ties:

  • Obtain­ing US guid­ance doc­u­ments and stan­dards
  • Inter­pre­ta­tion of US sub­mis­sions require­ments
  • Review draft sub­mis­sion doc­u­men­ta­tion (IDE, PMA, 510(K), HUD for exam­ple)
  • Assist­ing you in the devel­op­ment of label­ing, includ­ing user man­u­als, that meets US reg­u­la­to­ry and cus­tomer require­ments
  • For spe­cif­ic projects, direct­ly trans­lat­ing or arrang­ing the trans­la­tion of doc­u­ments and label­ing required for the sub­mis­sion
  • VISAMED can be your Autho­rized Rep­re­sen­ta­tive in Europe