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Success Story: Static Code Analysis – A validated tool chain for all projects

in collaboration with Sequana Medical NV

The Task

Sta­tic code ana­ly­sis is sta­te of the art in soft­ware deve­lo­p­ment. Various tools are avail­ab­le on the mar­ket. They veri­fy coding rules (for examp­le MISRA) and scan source code for bugs, vul­nera­bi­li­ties, and code smells.

Howe­ver, things are not always that easy. On the one hand, dif­fe­rent deve­lo­p­ment pro­jects use dif­fe­rent pro­gramming lan­guages and IDEs. Lega­cy code intro­du­ces depen­den­ci­es which are not necessa­ri­ly com­pa­ti­ble with the cur­rent envi­ron­ment. On the other hand, the tools used for sta­tic code ana­ly­sis should be easy to use. Ide­al­ly, all source code pro­jects are scan­ned using the same set of com­man­ds, even if dif­fe­rent tools are used.

The chal­len­ge con­sis­ted in buil­ding one sin­gle tool envi­ron­ment for sta­tic code ana­ly­sis of source code in C and C#, taking all tho­se restric­tions into account.

Static Code Analysis – A validated tool chain for all projects
Was hat Validierung mit der Entwicklung von eingebetteter Software für medizinische Geräte zu tun?

So funktioniert Validierung für medizinische Software

In die­sem Tech-Talk-Video erfah­ren Sie von unse­rem Exper­ten Tors­ten Her­bert, wie ein struk­tu­rier­tes, metho­di­sches Vor­ge­hen bei der Vali­die­rung zu einer nach­voll­zieh­ba­ren, kon­trol­lier­ba­ren Doku­men­ta­ti­on führt, womit auch anspruchs­vol­le Audits kein Pro­blem mehr sind.

Tech Talk ansehen

The Approach

Due to the spe­cial requi­re­ments men­tio­ned abo­ve, dif­fe­rent scan tools were selec­ted for C and C#. The results of the C scan are inte­gra­ted into the tool used to scan C# whe­re they are then mana­ged and assessed.

For each pro­gramming lan­guage, a default rule set was defi­ned, taking the pro­prie­ta­ry coding gui­de­li­nes at Sequa­na Medi­cal into account. In addi­ti­on, the repor­ting func­tion was exten­ded to be able to gene­ra­te audit-pro­of scan reports.

The tool envi­ron­ment was vali­da­ted accord­ing to the requi­re­ments of ISO 13485 chap­ter 7.6 and 21 CFR 820.70(i).

Success Factors

To impro­ve usa­bi­li­ty and to faci­li­ta­te auto­ma­ti­on, the scan is per­for­med using a scan script. The scripts are para­me­teri­zed in a way that they are easy to adapt to new pro­jects. The hand­ling is strict­ly iden­ti­cal for C and C#.

The built-in repor­ting fea­tures were exten­ded to align the ter­mi­no­lo­gy with Sequa­na pro­ces­ses and to com­ply with good docu­men­ta­ti­on practices.

Tool vali­da­ti­on was per­for­med using a risk- and work­flow-based approach.

Conclusion

“I have to say, I am very satis­fied with the Sonar­Qu­be Tool Envi­ron­ment: now that I am using that, I have to say it is very simp­le and intuitive.”
Alex Zan­fan­ti, Medi­cal Device Engi­neer Soft­ware SME

Sequana Medical NV

Sequa­na Medi­cal is a com­mer­cial sta­ge medi­cal device com­pa­ny deve­lo­ping the alfa­pump® plat­form for the tre­at­ment of flu­id over­load in liver dise­a­se, mali­gnant asci­tes and heart fail­u­re whe­re diure­tics are no lon­ger effec­ti­ve. The alfa­pump® is a ful­ly implan­ta­ble, pro­gramm­a­ble, wire­less­ly char­ged, bat­te­ry-powe­red sys­tem that is CE-mar­ked for the tre­at­ment of refrac­to­ry asci­tes due to liver cirrho­sis and mali­gnant ascites.

The alfa­pump® sys­tem is not cur­r­ent­ly appro­ved in the United Sta­tes or Cana­da. In the United Sta­tes and Cana­da, the alfa­pump® sys­tem is cur­r­ent­ly under cli­ni­cal inves­ti­ga­ti­on (POSEIDON Stu­dy) and is being stu­di­ed in adult pati­ents with refrac­to­ry or recur­rent asci­tes due to cirrhosis.

The DSR® the­ra­py is still in deve­lo­p­ment, and it should be noted that any state­ments regar­ding safe­ty and effi­cacy ari­se from ongo­ing pre-cli­ni­cal and cli­ni­cal inves­ti­ga­ti­ons which have yet to be com­ple­ted. The DSR® the­ra­py is not cur­r­ent­ly appro­ved for cli­ni­cal rese­arch in the United Sta­tes or Cana­da. The­re is no link bet­ween the DSR® the­ra­py and ongo­ing inves­ti­ga­ti­ons with the alfa­pump® sys­tem in Europe.

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Felix Win­ter, Busi­ness Deve­lo­p­ment Consultant