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



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



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


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


Con­sult­ing and approval

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


Integ­ra­tion services

Via adapter or as a part­ner for new or fur­ther devel­op­ments of your product lines — we integ­rate your med­ic­al product accord­ing to the open IEEE 11073 SDC stand­ard into the OR device net­work of the future


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.


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!

CARAD risk man­age­ment software

Risk man­age­ment for med­ic­al devices 

The DIN EN ISO 14971 stand­ard applies to risk man­age­ment and thus risk ana­lys­is spe­cific­ally to med­ic­al devices. Accord­ing to this, a risk man­age­ment file must be cre­ated for each med­ic­al device in which the risk ana­lys­is includ­ing risk assess­ment and risk con­trol, as well as inform­a­tion from the life cycle phases after deliv­ery of the product are sum­mar­ized and doc­u­mented. It must be ensured that all respons­ible per­sons also have the neces­sary spe­cial­ist know­ledge and exper­i­ence. This must also be doc­u­mented in the risk man­age­ment file.


The CARAD risk software 

CARAD is soft­ware spe­cially designed to sim­pli­fy the risk man­age­ment pro­cess. The input of risk ana­lyzes with CARAD is pro­cess-ori­ented on the basis of the F ail­ure- M ode and E ffect — A nalys­is (FMEA). At the same time, a cor­res­pond­ing fault tree ana­lys­is can be car­ried out at any time. Through the com­bin­a­tion of FMEA and fault tree ana­lys­is, not only can the poten­tial weak points of the sys­tem be eas­ily iden­ti­fied, but their causes can also be eas­ily assigned.

In order to increase the clar­ity, them­at­ic­ally related pro­cess steps are grouped into pro­cesses. Pro­cesses can be grouped togeth­er with fur­ther pro­cess steps to form high­er-level pro­cesses, so that at the end a tree struc­ture arises with pro­cesses as branches and pro­cess steps as leaves.

The form of the risk ana­lys­is report gen­er­ated with CARAD cor­res­ponds to the FMEA form. For each error, all com­bin­a­tions of cause and con­sequence are determ­ined and entered in a sep­ar­ate line of the table below the cur­rent work step with the cor­res­pond­ing risk fig­ures. The risk num­bers used to cal­cu­late the RPN (risk pri­or­ity num­ber) are depend­ent on the gen­er­ic causes as well as on pre­vi­ous and sub­sequent errors.

The risk ana­lys­is report is out­put in PDF format.

CARAD runs on Win­dows 7, 8.x and 10.

CARAD is sup­por­ted by the fol­low­ing Win­dows 10 edi­tions: Win­dows 10 Pro and Win­dows 10 Enterprise.

Fur­ther information 

Inform­a­tion on eval­u­ation and com­par­is­on with oth­er tools 

More inform­a­tion about the CARAD soft­ware (down­load flyer) 

Addi­tion­al reading 
As an intro­duct­ory read­ing, we recom­mend the book by Prof. Dr. Jür­gen P. Bläsing “Med­iz­in­produkte: Risiko­man­age­ment im Lebenszyklusmodell”.

Down­load the software 
Please write to us without oblig­a­tion to: office [at] We will be happy to send you a free tri­al version.

Integ­ra­tion services

SurgiTAIX AG has been involved in the open, cross-man­u­fac­turer net­work­ing of med­ic­al devices for almost 15 years. In the research pro­jects OrthoMIT and OR.NET, vari­ous stand­ards for the net­work­ing of med­ic­al devices were defined and trans­ferred to stand­ard­iz­a­tion. The res­ult was the IEEE 11073 SDC fam­ily of stand­ards, namely BICEPS, MDPWS and Archi­tec­ture Bind­ing. In the research pro­jects ZiMT, MoVE, MOMENTUM and PriMed, applic­a­tion scen­ari­os as well as approv­ab­il­ity and test pro­ced­ures were researched. The res­ults of these research pro­jects flow into the defin­i­tion of the so-called Par­ti­cipant Key Pur­poses, which are cur­rently in the bal­lot­ting phase of stand­ard­iz­a­tion. The PKPs define the require­ments for devices depend­ing on their func­tion, for example, for devices that can be con­trolled extern­ally or that issue or pro­cess alarms. Sim­il­arly, the so-called Device Spe­cial­iz­a­tions are cur­rently being derived, in which the require­ments for spe­cif­ic classes of devices such as RF devices, syr­inge pumps or oper­at­ing tables are col­lec­ted. The stand­ard­iz­a­tion was and is act­ively accom­pan­ied by SurgiTAIX AG.

sdcX — The com­mer­cial SDC library

In addi­tion, SurgiTAIX AG has been act­ive in the field of SDC lib­rar­ies and soft­ware stacks for years. Such a stack enables a med­ic­al device man­u­fac­turer without in-depth know­ledge of the stand­ards to net­work his device via SDC. The stack takes on the role of a com­mu­nic­a­tion lib­rary and ful­fills large parts of the require­ments of the IEEE 11073 SDC fam­ily of stand­ards. Pre­vi­ous, pub­licly avail­able SDC stacks such as the SDCLib / C developed by SurgiTAIX ( ) and SDCLib / J ( ) were primar­ily designed for use in demon­strat­ors and for tech­no­logy eval­u­ation. Use in com­mer­cial products was dif­fi­cult due to the lack of doc­u­ment­a­tion and risk assess­ment. The C ++ lib­rary sdcX, newly developed by SurgiTAIX, is the first stack that con­siders and ful­fills the require­ments for com­mer­cial oper­a­tion. sdcX imple­ments large parts of the three 11073 SDC core stand­ards as well as parts of the PKP sub­stand­ards that are cur­rently under development.

The use of cur­rent tech­no­lo­gies and pro­gram­ming meth­ods enables high per­form­ance with mod­er­ate memory and resource con­sump­tion at the same time. The lib­rary can be used regard­less of the mode of oper­a­tion of the device or value-added ser­vice, as it sup­ports dif­fer­ent pro­cess mod­els (call­backs, asyn­chron­ous pro­gram­ming, thread pool­ing).A focus dur­ing devel­op­ment was placed on the extens­ib­il­ity of the lib­rary — the X in the name stands for eXtens­ible. Through an extens­ible log­ger, logs gen­er­ated by the lib­rary can be integ­rated dir­ectly into the user’s own device-spe­cif­ic log­gers. Like­wise own eval­u­ations can take place by a mul­ti­pli­city of sub­scrib­able noti­fic­a­tions, for example with the entrance of a new mes­sage of a cer­tain type. This allows the lib­rary to be used in vari­ous use cases and fields.

The lib­rary sup­ports com­mon ARM and x86 sys­tems with Win­dows or Linux as oper­at­ing sys­tem. Cross com­pilers for Buil­d­root or Yocto Linux can be integ­rated par­tic­u­larly quickly due to the CMake-based build pro­cess used. A com­pre­hens­ive test suite is avail­able on request for test­ing the lib­rary on the tar­get plat­form. In this suite all parts of the stand­ards and the lib­rary are tested and evaluated.

In addi­tion to extens­ive doc­u­ment­a­tion, a com­pre­hens­ive risk ana­lys­is and IEC 62304-com­pli­ant devel­op­ment doc­u­ment­a­tion are also provided.
Already dur­ing devel­op­ment, IT secur­ity require­ments were determ­ined and con­sidered by a secur­ity pro­cess. This doc­u­ment­a­tion of the pro­cess as well as the con­sidered risks can be integ­rated into a doc­u­ment­a­tion for the cur­rently val­id “FDA Pre­market Sub­mis­sion for Man­age­ment of Cyber­se­cur­ity in Med­ic­al Devices”. The status of SOUP com­pon­ents will be con­tinu­ously reviewed.

The require­ments for med­ic­al devices are becom­ing more strin­gent, as are the demands of med­ic­al devices on the infra­struc­ture. Espe­cially miss­ing con­sid­er­a­tion of real-time require­ments as well as inter­fer­ing cables com­plic­ate or pre­vent innov­at­ive use cases. To this end, the 5G-FORUM research pro­ject will expand the lib­rary to include sup­port for real-time cap­able 5G net­work­ing with TSN. In the medi­um term, this will enable the lib­rary to be used in crit­ic­al areas such as the con­trol of con­trol elec­tron­ics, ima­ging or in robotics.

Interest piqued? Con­tact us for more information