Vali­da­ti­on Sup­port for Satisfy­ing the New Medi­cal Device Regu­la­ti­on


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 is here to help. Over the past six mon­ths, we have been working to deve­lop a stan­dard pro­cess that pro­vi­des our cus­to­mers with the best sup­port. What we found is that by inte­gra­ting our equip­ment vali­da­ti­on into our pro­ject pro­cess, we can help ease the pres­su­re of vali­da­ti­on. Here’s how it works. At the begin­ning of the pro­ject, we will crea­te a cus­to­mi­zed plan that sup­ports the level of docu­men­ta­ti­on you desi­re to satisfy the EU-MDR. Once the plan is in place, our team works with you throughout the pro­ject to ensu­re you have the necessa­ry equip­ment infor­ma­ti­on to meet your needs.


Below is a quick over­view of our Three-Pha­se Vali­da­ti­on Pro­cess along with the level of docu­men­ta­ti­on you can choo­se from. Com­ple­te pro­gram infor­ma­ti­on can be found here. This pro­gram is cur­r­ent­ly avail­ab­le at our Euro­pean faci­li­ty in Vil­lin­gen-Schwen­nin­gen, Ger­ma­ny. We hope to roll out a simi­lar pro­gram for US-based cus­to­mers later this year.

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