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Ensure the safe manufacture and testing of medical device assemblies.

KOMOS manu­fac­tures and tests medi­cal tech­no­lo­gy assem­blies accor­ding to ISO 13485 – using pla­s­tic injec­tion mol­ding, CNC tur­ning parts, cable assem­bly, assem­bly and elec­tri­cal test­ing.

We take respon­si­bi­li­ty for the inter­ac­tion of the com­pon­ents – from the tech­ni­cal cla­ri­fi­ca­ti­on through assem­bly and test­ing to sta­ble mass pro­duc­tion.

Dis­cuss medi­cal tech­no­lo­gy pro­ject
  1. Start
  2. Indus­tries
  3. Medi­cal tech­no­lo­gy

Are you familiar with these regulatory challenges?

Why medical technology companies trust us

Regulatory system responsibility

KOMOS manu­fac­tures medi­cal tech­no­lo­gy assem­blies in a qua­li­ty manage­ment sys­tem cer­ti­fied to ISO 13485 – with clear requi­re­ments, docu­men­ted pro­ces­ses, and unam­bi­guous respon­si­bi­li­ty.

Validated quality from the sample to the series

Tracea­bi­li­ty, test­ing plan­ning, and vali­da­ted pro­ces­ses ensu­re repro­du­ci­b­le results from pro­to­ty­pe deve­lo­p­ment to sta­ble mass pro­duc­tion.

Integration for critical systems

Mecha­nics, elec­tro­nics, data, power, wiring, cable assem­bly, assem­bly, and elec­tri­cal test­ing are all con­nec­ted to func­tion­al assem­blies – with docu­men­ted pro­ces­ses and traceable qua­li­ty.

What KOMOS brings to medical technology projects

Application experience

  • Ven­ti­la­ti­on equip­ment com­pon­ents: Pre­cis­e­ly matched assem­blies and fine-machi­ned parts
  • Gas sup­p­ly com­pon­ents: Spe­cia­li­zed val­ve and flow regu­la­tor assem­blies for medi­cal gas sys­tems
  • Medi­cal infra­struc­tu­re: Spe­cia­li­zed socket strips and spe­cial cables for ope­ra­ting thea­tres and inten­si­ve care are­as

Quality and documentation

  • ISO 13485-cer­ti­fied manu­fac­tu­ring as a relia­ble basis for regu­la­to­ry requi­re­ments
  • Relia­ble part­ner for stan­dard-com­pli­ant medi­cal tech­no­lo­gy deve­lo­p­ment
  • <10 ppm fail­ure rates: Hig­hest qua­li­ty and relia­bi­li­ty for cri­ti­cal medi­cal devices

Production and testing

  • ESD-com­pli­ant pro­duc­tion: Anti­sta­tic pro­duc­tion envi­ron­ment for sen­si­ti­ve medi­cal com­pon­ents
  • Vali­da­ted pro­ces­ses: ISO 13485-com­pli­ant pro­duc­tion pro­ces­ses with com­ple­te docu­men­ta­ti­on
  • Func­tion­al and safe­ty tests accor­ding to estab­lished test­ing plans and pro­ject-spe­ci­fic requi­re­ments

Bring the medical technology assembly unit to production safely.

Talk to KOMOS about your regu­la­ted assem­bly – from tech­ni­cal cla­ri­fi­ca­ti­on, pro­to­ty­pe con­s­truc­tion and assem­bly to elec­tri­cal test­ing and docu­men­ted seri­al pro­duc­tion in accordance with ISO 13485.

  • Free com­pli­ance ana­ly­sis for your medi­cal tech­no­lo­gy requi­re­ments
  • Appr­oval opti­miza­ti­on from deve­lo­p­ment to mar­ket release
  • Request tech­ni­cal cla­ri­fi­ca­ti­on
Dis­cuss medi­cal tech­no­lo­gy assem­bly

Frequently asked questions

How does KOMOS sup­port regu­la­ted medi­cal device assem­blies?

KOMOS sup­ports with ISO-13485 pro­ces­ses, docu­men­ted manu­fac­tu­ring, tracea­bi­li­ty, assem­bly and elec­tri­cal test­ing. Regu­la­to­ry respon­si­bi­li­ty for the medi­cal device remains with the manu­fac­tu­rer.

How long does it take to deve­lop a medi­cal device?

Through our par­al­lel deve­lo­p­ment and pre-qua­li­fied plat­form, we shor­ten the usu­al deve­lo­p­ment time by 6 months. Fur­ther­mo­re, our exis­ting cer­ti­fi­ca­ti­on eli­mi­na­tes the addi­tio­nal audit for your pro­ject.

Which mate­ri­als are appro­ved for medi­cal devices?

We pro­cess bio­com­pa­ti­ble pla­s­tics (USP Class VI), stain­less steel (316L), and other medi­cal­ly appro­ved mate­ri­als.

Which manu­fac­tu­ring pro­ces­ses do you use for medi­cal pro­ducts?

Injec­tion mol­ding for housings, pre­cis­i­on machi­ning for metal com­pon­ents, and addi­ti­ve manu­fac­tu­ring for pro­to­ty­pes and small series.

How do you ensu­re stan­dards-com­pli­ant docu­men­ta­ti­on?

Our KOMOS app auto­ma­ti­cal­ly docu­ments all qua­li­ty-cri­ti­cal pro­cess steps in accordance with stan­dards. Test reports are auto­ma­ti­cal­ly gene­ra­ted and, if desi­red, sent to you – this signi­fi­cant­ly speeds up the appr­oval pro­cess and docu­men­ta­ti­on.

Does KOMOS manu­fac­tu­re accor­ding to ISO 13485?

Yes. KOMOS works with ISO-13485 pro­ces­ses for medi­cal device requi­re­ments and sup­ports docu­men­ted manu­fac­tu­ring, assem­bly, and test­ing.

Can KOMOS Medi­zin­tech­nik check the elec­tri­cal com­pon­ents?

Yes. KOMOS per­forms elec­tri­cal tests tail­o­red to the assem­bly unit and docu­ments the results for veri­fia­ble qua­li­ty.

Does KOMOS inte­gra­te data and power inter­faces?

Yes. KOMOS cla­ri­fies ear­ly on how data trans­mis­si­on, power sup­p­ly, cont­act con­nec­tions, cable rou­ting, housing and assem­bly must work tog­e­ther to ensu­re that assem­blies are func­tion­al, moun­ta­ble and test­a­ble.