Regulatory

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

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

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