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Invo­tec GmbH offers equip­ment vali­da­ti­on as part of com­pa­nies’ pro­cess vali­da­ti­on

Vil­lin­gen-Schwen­nin­gen, Ger­ma­ny – The new Invo­tec pro­cess offers sup­port for com­pa­nies to satisfy the new Euro­pean Medi­cal Device Regu­la­ti­on (EU-MDR).

Invo­tec is now offe­ring a new equip­ment vali­da­ti­on pro­gram to sup­port medi­cal device manu­fac­tu­rers facing impli­ca­ti­ons from the new Euro­pean Medi­cal Device Regu­la­ti­on (EU-MDR).

Set to take effect this year, the EU-MDR will requi­re medi­cal device manu­fac­tu­rers to meet hig­her docu­men­ta­ti­on requi­re­ments wit­hin a shor­ter repor­ting deadline—meaning many manu­fac­tu­rers are facing a signi­fi­cant incre­a­se in effort during the vali­da­ti­on pro­cess. Invo­tec GmbH has deve­lo­ped over the past six mon­ths a stan­dard pro­cess that pro­vi­des cus­to­mers with the best sup­port. The inte­gra­ti­on of equip­ment vali­da­ti­on into the pro­ject pro­cess eases the pres­su­re of vali­da­ti­on.

During the plan­ning pha­se, Invo­tec works with the cus­to­mer to crea­te a cus­to­mi­zed pro­ject plan and defi­ne the necessa­ry docu­men­ta­ti­on to satisfy the EU-MDR. The fol­lowing design pha­se builds on the­se defi­ni­ti­ons and works to mini­mi­ze risks through con­trol­led docu­men­ta­ti­on of the deve­lo­p­ment. Final­ly, in the tes­ting pha­se, the func­tio­n­a­li­ty is veri­fied and docu­men­ta­ti­on for the per­for­mance of the equip­ment is pro­vi­ded.

Des­pi­te the stream­li­ned pro­cess, cus­to­mers can choo­se from fle­xi­ble opti­ons throughout the pro­cess, ensu­ring that they have the necessa­ry equip­ment infor­ma­ti­on to meet their indi­vi­du­al needs.

Experts from the Invo­tec team in Vil­lin­gen-Schwen­nin­gen, Ger­ma­ny will be avail­ab­le for inter­view at Phar­ma­pack Euro­pe 2020 on Febru­a­ry 5 – 6 (Booth #B2) to exp­lain the pro­cess, talk about latest advan­ces in auto­ma­ti­on and dis­cuss this pro­gram. The roll­out of a simi­lar pro­gram for US-based cus­to­mers is plan­ned for later this year.

Wal­dorf Tech­nik GmbH, a sis­ter com­pa­ny of Invo­tec wit­hin the HAHN Group, will also be at Phar­ma­pack Euro­pe. Wal­dorf Tech­nik is also acti­ve in both the medi­cal tech­no­lo­gy and health­ca­re indus­tries. At the fair, they will high­light the Vario TIP® system—the paten­ted, world­wi­de lea­ding sys­tem con­cept for manu­fac­tu­ring pipet­te tips and blood reagent con­tai­ners. The sys­tem ensu­res maxi­mum pro­duc­ti­vi­ty and incre­a­sed pati­ent safe­ty. In addi­ti­on to pro­ven cycle times of up to 4.5 seconds and high cavi­ty num­bers of up to 128, the Vario TIP® sys­tems stand out with their extre­me­ly space-saving design and com­ple­te cavi­ty sor­ting.

 

 

About Invo­tec

Invo­tec designs and builds cus­tom assem­bly, test, and inspec­tion equip­ment for medi­cal device manu­fac­tu­rers. The com­pa­ny has three pro­duc­tion sites in Vil­lin­gen-Schwen­nin­gen, Ger­ma­ny, in Miamis­burg, Ohio, USA, and in Brook­lyn Park, Min­ne­so­ta, USA. Invo­tec spe­cia­li­zes in app­li­ca­ti­ons with small-to-medi­um-sized com­pon­ents and com­pli­ca­ted assem­bly pro­ces­ses — pro­vi­ding a ran­ge of robust, reli­able, semi-auto­ma­ted and ful­ly-auto­ma­ted solu­ti­ons. Invo­tec’s fle­xi­ble approach allows cus­to­mers to refi­ne their pro­duct design while Invo­tec engi­neers the equip­ment. As part of the HAHN Group’s Assem­bly & Test Divi­si­on sin­ce 2017, Invo­tec is able to leverage a net­work of best prac­ti­ces and glo­bal sup­port. For more infor­ma­ti­on visit www.invotec.com.

 

About Wal­dorf Tech­nik GmbH

Wal­dorf Tech­nik is spe­cia­li­zed in auto­ma­ti­on for injec­tion mol­ding pro­ces­ses in the medi­cal and pack­a­ging indus­tries. The com­pa­ny cur­r­ent­ly employs appro­xi­mate­ly 100 staff in Engen, Ger­ma­ny. Based on more than 30 years of expe­ri­ence, auto­ma­ti­on from Wal­dorf Tech­nik excels with cycle times bet­ween 2 – 20 seconds and a high num­ber of cavi­ties. Sin­ce 2016 the com­pa­ny is also part of the HAHN Group’s Mate­ri­al Hand­ling Divi­si­on. For more infor­ma­ti­on visit www.waldorf-technik.de/en.

 

About HAHN Group GmbH

The HAHN Group con­sists of a net­work of spe­cia­li­zed com­pa­nies for indus­tri­al auto­ma­ti­on and robot solu­ti­ons. With its own pro­duc­tion sites the group cur­r­ent­ly employs approx. 1,400 staff at 27 loca­ti­ons. Well-known cus­to­mers from the auto­mo­ti­ve, con­su­mer goods, elec­tro­nics, medi­cal tech­no­lo­gy, and health­ca­re indus­tries bene­fit from the HAHN Group’s 30 years of exper­ti­se and auto­ma­ti­on know-how. For more infor­ma­ti­on visit www.hahn.group/en.

 

Press con­ta­ct: Cor­du­la Knüp­pel | pho­ne: +49 162 10 45 056| c.knueppel@hahn.group

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