Services

Soft­ware

Regard­less if C++, C#, Java or Python — our devel­op­ment team speaks our lan­guage. All our soft­ware is developed and doc­u­mented stand­ard-com­pli­ant in a pro­duct­ive SCRUM envir­on­ment

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Elec­tron­ics

We offer stand­ard-com­pli­ant hard and soft­ware devel­op­ment for simple and more com­plex mechat­ron­ic sys­tems

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Pro­to­typ­ing

We cre­ate func­tion­al mod­els and pro­to­types accord­ing to your ideas using gen­er­at­ive man­u­fac­tur­ing and as well as CNC-Drilling. Togeth­er with our part­ners we accom­pany you with every step to series pro­duc­tion

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Pro­ject coordin­a­tion and pro­ject man­age­ment

In the inter­dis­cip­lin­ary field of med­ic­al tech­no­lo­gies com­mu­nic­a­tion between the devel­op­ment part­ners is the cru­cial part of accom­plish­ing a well-roun­ded pro­ject

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Con­sult­ing and approv­al

We con­sult you regard­ing approv­al, qual­ity and risk man­age­ment and inter­op­er­ab­il­ity (IEEE 11073)

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Soft­ware devel­op­ment

Wheth­er embed­ded or stan­dalone soft­ware: the pur­pose determ­ines wheth­er soft­ware is to be clas­si­fied as an (inde­pend­ent) med­ic­al device.
We sup­port you from there onwards and accom­pany you through all the steps of devel­op­ment. You will be involved in our devel­op­ment pro­cess, which is prefer­ably agile. For us, agil means first of all: require­ments are always wel­come, at any time. And secondly, we deliv­er res­ults that you can check at any time — even dur­ing devel­op­ment.

In addi­tion, we devel­op test driv­en. Writ­ing many auto­mated tests serves the sta­bil­ity and good archi­tec­tur­al design that are essen­tial for a med­ic­al device.

The stand­ards rel­ev­ant for soft­ware devel­op­ment, such as IEC 62304, must be observed in every devel­op­ment pro­cess. For this reas­on, soft­ware devel­op­ment ends with doc­u­ment­a­tion that is com­pli­ant to stand­ards, which we pro­duce dur­ing devel­op­ment.

Devel­op­ment of elec­tron­ics

Your com­pany wants to devel­op, approve or pro­duce a med­ic­al product? Thanks to our many years of exper­i­ence, we can sup­port you in ever phase of the devel­op­ment pro­cess. We find the right step in the pro­cess to accom­pany you from the idea to approv­al, if desired. Our com­pact mul­tidi­cip­lin­ary team sup­ports you find­ing a fast, cost-effi­ci­ant and high qual­ity solu­tion.

Pro­to­typ­ing

Our large-volume gen­er­at­ive man­u­fac­tur­ing sys­tem from Ger­man Reprap and our 3-axis CNC milling machine from Isel with mod­ern high-fre­quency spindle ensure the fast pro­duc­tion of high-qual­ity func­tion­al samples. Our net­work of part­ners in the region includes com­puter-aided met­al part machin­ing (CNC), prin­ted cir­cuit board man­u­fac­tur­ers and gen­er­at­ive man­u­fac­tur­ing tech­no­lo­gies com­pan­ies to pro­duce first-class pro­to­types for your product. The assembly of mech­an­ic­al assem­blies and elec­tron­ic cir­cuits can be car­ried out on site. We are look­ing for­ward to turn­ing your concept into real­ity.

Pro­ject coordin­a­tion and man­age­ment

In addi­tion to the devel­op­ment of mech­an­ic­al and elec­tric­al com­pon­ents, soft­ware tech­no­logy in par­tic­u­lar has become increas­ingly import­ant in recent years. Due to the digit­iz­a­tion and net­work­ing of the dif­fer­ent sys­tems, a large num­ber of oth­er dis­cip­lines have been brought on the agenda, each of which can only be ful­filled by highly spe­cial­ized IT pro­viders.

Due to the high degree of spe­cial­iz­a­tion of the devel­op­ment ser­vice pro­viders in their indi­vidu­al core com­pet­ences, how­ever, it is increas­ingly neces­sary that the devel­op­ment of com­plex med­ic­al tech­no­logy sys­tems can only be car­ried out in cooper­a­tion.

In addi­tion to tra­di­tion­al engin­eer­ing offices, this includes spe­cial­ized soft­ware pro­viders sup­por­ted by uni­ver­sity insti­tutes and clin­ic­al part­ners. Exper­i­enced pro­ject coordin­a­tion is cru­cial for these het­ero­gen­eous con­sor­tia to work togeth­er effect­ively. SurgiTAIX has 15 years of exper­i­ence in coordin­at­ing research pro­jects as well as indus­tri­al pro­jects and speaks the “lan­guages” of the vari­ous cooper­a­tion part­ners.

 

Con­sult­ing: Qual­ity and risk man­age­ment ser­vice pro­viders

Qual­ity and risk man­age­ment are two con­cepts that are inher­ently linked to med­ic­al devices. In accord­ance with the Med­ic­al Devices Act, every man­u­fac­turer of med­ic­al devices is obliged to provide tech­nic­al doc­u­ment­a­tion for each of its products. This doc­u­ment­a­tion must be pre­pared in accord­ance with a qual­ity man­age­ment sys­tem and main­tained through­out the entire life­cycle of the product.

In par­tic­u­lar, the fol­low­ing laws, stand­ards, and dir­ect­ives must be com­plied with:

  • Med­ic­al Devices Act (“Med­iz­in­produk­tege­setz”)
  • Dir­ect­ive 93/42/EEC and MDR (Med­ic­al Device Reg­u­la­tion)
  • Qual­ity man­age­ment accord­ing to DIN EN ISO 13485
  • Risk man­age­ment accord­ing to DIN EN ISO 14971
  • Elec­tric­al safety DIN EN 60601–1
  • Usab­il­ity test accord­ing to DIN EN 60601–1-6
  • Soft­ware devel­op­ment accord­ing to DIN EN 60601–1-4 and DIN EN 62304

SurgiTAIX AG offers an adap­ted con­sult­ing pack­age espe­cially for new com­pan­ies and spin-offs. We offer all con­sult­ing ser­vices from a single source, start­ing with the devel­op­ment of a QM sys­tem, sup­port in the cre­ation of tech­nic­al doc­u­ment­a­tion and sup­port dur­ing the approv­al pro­cess.

In addi­tion to pure con­sult­ing ser­vices, we offer train­ing courses and lec­tures on the fol­low­ing top­ics:

  • Qual­ity man­age­ment for med­ic­al devices
  • Risk man­age­ment for med­ic­al devices
  • Tech­nic­al doc­u­ment­a­tion
  • Dir­ect­ive con­form­ant devel­op­ment of elec­tron­ics, soft­ware, and hard­ware
  • Elec­tric­al safety

The highest qual­ity and safety are at the fore­front of our ser­vices. Bene­fit from our many years of exper­i­ence in qual­ity and risk man­age­ment for your products!