Tentamus establishes TentaStart for medical device start-up companies

On 26 May 2021, after a one-year post­pone­ment, The pre­sen­ta­tion of the process­es around the Med­ical Device Reg­u­la­tion (MDR) will now become valid. It is com­plex and not always trans­par­ent, espe­cial­ly for young mar­ket par­tic­i­pants (com­pa­ny founders, uni­ver­si­ty start-ups or spin-offs, small manufacturers).

The Ten­taS­tart mod­el of the Ten­ta­mus Group is specif­i­cal­ly tai­lored for this tar­get group and is now com­ple­ment­ed by the great pro­fes­sion­al exper­tise as well as many years of mar­ket expe­ri­ence of Ten­ta­Con­sult in the field of med­ical devices. “Just in time to help these clients to over­come the often great dis­ori­en­ta­tion of small com­pa­nies in a legal frame­work that is already extreme­ly com­plex due to the tran­si­tion from the MDD (Med­ical Device Direc­tive) to the MDR, we have decid­ed to offer the ser­vice already estab­lished in oth­er prod­uct areas for med­ical devices at very short notice,” explains Ralf Sib­bing, Man­ag­ing Partner.

“We know that the appli­ca­tion of the new Reg­u­la­tion (EU) 2017/745 is a par­tic­u­lar­ly big headache for many young mar­ket par­tic­i­pants. So, we want to make the start of coop­er­a­tion with us par­tic­u­lar­ly reward­ing and, above all, uncom­pli­cat­ed with a full-ser­vice offer — pre­cise­ly sup­port­ed by the accred­it­ed lab­o­ra­to­ries of the Ten­ta­mus Group — and an attrac­tive intro­duc­to­ry price for this tar­get group.”

- Anja Heinrich

In the first year of coop­er­a­tion, the com­pa­ny grants a 10 % dis­count on all prices for con­sult­ing and ser­vices as well as the analy­ses of the Ten­ta­mus lab­o­ra­to­ries. An indi­vid­ual ini­tial con­sul­ta­tion on the prin­ci­ples of con­for­mi­ty assess­ment and first plac­ing on the mar­ket is of course includ­ed for start-ups.