Clinical Evaluation

Pre-clinical Investigation, Clinical Investigation and Clinical Evaluation

The out­come of pre-clin­i­cal inves­ti­ga­tions can be used to get ear­ly cus­tomer feed­back on prod­ucts. This feed­back can be used to improve your prod­uct design, to define your mar­ket­ing strat­e­gy and your prod­uct posi­tion­ing. Fur­ther­more, a prop­er­ly design clin­i­cal study should sup­port the mar­ket­ing strat­e­gy and help Research and Devel­op­ment for the cre­ation of next gen­er­a­tion prod­uct. In con­clu­sion, pre-clin­i­cal and clin­i­cal inves­ti­ga­tions with added R/D and mar­ket­ing val­ue can help you to devel­op and intro­duce to the mar­ket a supe­ri­or prod­uct in a time­ly manner.

Pre-clinical investigations

To ensure a suc­cess­ful devel­op­ment and launch of your new or mod­i­fied prod­ucts, VISAMED offers you the pos­si­bil­i­ty to eval­u­ate your prod­ucts using in vit­ro and in vivo mod­els. VISAMED can help you in design­ing and per­form­ing bench test and acute and/or chron­ic ani­mal stud­ies. Those stud­ies can serve as prod­uct design ver­i­fi­ca­tion and val­i­da­tion. As a result, those stud­ies will sup­port the essen­tial require­ments (Med­ical Device Direc­tive, 93/42/EEC, Annex I) and glob­al reg­u­la­to­ry fil­ing. VISAMED pro­vides the fol­low­ing services:

  • Iden­ti­fy standards/guidelines and require­ments for in vit­ro and in vivo testing
  • Devel­op prod­uct test­ing strat­e­gy in com­pli­ance with iden­ti­fied requirements
  • Design, coor­di­nate and/or per­form testing

Clinical Investigations

VISAMED can help you to man­age your clin­i­cal study by assist­ing you with:

  • the selec­tion of the appro­pri­ate clin­i­cal strategy
  • the selec­tion of suit­able investigators
  • the Design of clin­i­cal plans and con­for­mi­ty with the Euro­pean har­mo­nized stan­dards EN ISO 14155 series
  • the Insur­ance coverage
  • the Applications/Notification to Eth­i­cal com­mit­tees and Euro­pean com­pe­tent authorities
  • the Study ini­ti­a­tion and monitoring
  • the Data man­age­ment and analysis

Clinical Evaluation

VISAMED is prepar­ing clin­i­cal eval­u­a­tions for your prod­ucts by apply­ing MEDDEV 2.7.1. The eval­u­a­tion of clin­i­cal data is not only of prime impor­tance for the offi­cial approval process and prod­uct launch, but also for the con­tin­u­ing mar­ket sur­veil­lance in the field of med­ical devices.

The clin­i­cal eval­u­a­tion is based on a com­pre­hen­sive analy­sis of avail­able pre-and post mar­ket clin­i­cal data rel­e­vant to the intend­ed use of the device in ques­tion, includ­ing clin­i­cal per­for­mance data and safe­ty data. This includes data spe­cif­ic to the device in ques­tion as well as any data relat­ing to devices claimed as equiv­a­lent by the man­u­fac­tur­er. The out­come of this process is a report which includes a con­clu­sion on the accept­abil­i­ty of risks and side effects when weighed against the intend­ed ben­e­fits of the device.

The eval­u­a­tion of clin­i­cal data is part of the tech­ni­cal doc­u­men­ta­tion and con­for­mi­ty assess­ment, and there­fore has to be sub­mit­ted to the noti­fied body as part of the offi­cial approval process for med­ical devices. The clin­i­cal eval­u­a­tion should be revised in reg­u­lar inter­vals based on the risk of the product.