From in­di­vi­du­al do­cu­ments to our do­cu­ment ma­nage­ment sys­tem and pro­cess-ori­en­ted dos­sier ma­nage­ment — our mo­du­le “d.velop life sci­en­ces | tech­ni­cal do­cu­ments” sup­ports and sim­pli­fies the crea­ti­on and up­dating of your tech­ni­cal do­cu­men­ta­ti­on, e.g. in the con­text of the re­qui­re­ments of the Me­di­cal De­vice Re­gu­la­ti­on (MDR). Our pro­cess-ori­en­ted dos­sier ma­nage­ment is ver­sa­ti­le, e.g. also for the crea­ti­on of site mas­ter files, tool log­books, drug mas­ter files, QM do­cu­men­ta­ti­on, pro­ject fol­ders, va­li­da­ti­on do­cu­men­ta­ti­on and much more.

How do you benefit from the Technical Documentation software?

Di­gi­tal management 

Make ma­nu­al do­cu­men­ta­ti­on of dos­siers a thing of the past — in­s­tead, ma­na­ge them com­ple­te­ly digitally. 

Struc­tu­red data maintenance 

Let un­ti­dy file ser­vers with mul­ti­ple sto­rage lo­ca­ti­ons and red­un­dant fol­der struc­tures be a thing of the past. 

In­cre­a­sed data security 

Pro­tect your data from un­wan­ted ac­tions of un­aut­ho­ri­zed users as well as from de­st­ruc­ti­ve for­ces and stop worry­ing about im­mi­nent data loss. 

In­di­vi­du­al configuration 

Let the mo­du­les be con­fi­gu­red ac­cord­ing to your wis­hes and pre­fe­ren­ces to fa­ci­li­ta­te the on­boar­ding trai­ning for your colleagues. 

Com­pli­an­ce with Me­di­cal De­vice Regulation 

Di­gi­tal­ly crea­te and up­date your tech­ni­cal do­cu­men­ta­ti­on wi­t­hin the re­qui­re­ments of the Me­di­cal De­vice Regulation. 

Mi­ni­miz­a­ti­on of runtimes 

Mi­ni­mi­ze pro­cess run­ti­mes for crea­ting, re­vi­sing and ap­pro­ving your dos­siers and re­du­ce un­ne­cessa­ry time spent on se­ar­ching and com­pi­ling the la­test documents. 

Cen­tral in­for­ma­ti­on platform 

Use the d.3ecm sys­tem as your cen­tral in­for­ma­ti­on plat­form on which you can re­trie­ve all your data at short notice. 

Con­stant availability 

Ac­cess your data at any time. It does not mat­ter whe­re you are. 

Here are some features of the Technical Documentation

Regulatory requirements for Technical Documentation

We would like to present you some features already

Illustration of a notebook on which the Technical Documentation of d.velop Life Sciences is displayed
Ad­ding documents

Mo­reo­ver, you can di­rect­ly ad­opt do­cu­ments from the eDMS/eQMS using the dos­sier tem­pla­te. Add ad­di­tio­nal do­cu­ments and at­tach­ments to the dos­sier ap­p­li­ca­ti­on and as­sign them to the re­spec­ti­ve chap­ters via drag & drop.

Print your dos­siers or ex­port them as a ZIP file or PDF/A. It is also pos­si­ble to print and/or ex­port only parts or cer­tain chap­ters of the dossier.

Drop Zone

Using the Drop Zone, non-con­trol­led and con­trol­led do­cu­ments can be stored via drag & drop. Do­cu­ments can also be as­si­gned di­rect­ly to the re­spec­ti­ve nodes/chapters in the dos­sier via drag & drop.

Rea­ding Pane

For each do­cu­ment, a pre­view can be dis­play­ed wi­t­hin the fle­xi­b­ly cus­to­miz­ab­le rea­ding pane.

Chap­ter structure

Crea­te tem­pla­tes and chap­ter struc­tures for your dos­siers ac­cord­ing to your needs and de­fi­ne re­spon­si­bi­li­ties for each part. Dos­sier tem­pla­tes, e.g. for the MDR tree struc­tu­re, are au­to­ma­ti­cal­ly in­clu­ded when the mo­du­le is implemented.

Would you like a live insight into the software?

Get a live in­sight into the pos­si­bi­li­ties of im­ple­men­ting a pro­cess-ori­en­ted dos­sier ma­nage­ment by me­ans of a sam­ple use case in only 45 mi­nu­tes. Learn how our so­lu­ti­on can sup­port and sim­pli­fy the crea­ti­on and up­dating of your tech­ni­cal do­cu­men­ta­ti­on wi­t­hin the re­qui­re­ments of the Me­di­cal De­vice Re­gu­la­ti­on (MDR).

33 Good reasons for a cooperation with d.velop LS

You’­re not con­vin­ced yet? Find out about 33 good re­a­sons spea­king for a coope­ra­ti­on with d.velop Life Sci­en­ces GmbH. We will show you re­a­sons from the provider’s point of view, from the soft­ware point of view and other ge­ne­ral re­a­sons that dis­tin­guish us. 

Frequently asked questions (FAQs) about Technical Documentation

Tem­pla­tes are avail­ab­le for fre­quent­ly used do­cu­men­ta­ti­on, e.g. ac­cord­ing to An­nex II of the MDR 2017/745. On the ba­sis of a struc­tu­re used by you, you can also amend tem­pla­tes yourself or have them crea­ted as part of the in­tro­duc­tion of the module.
You can cus­to­mi­ze chap­ter struc­tures and dos­sier tem­pla­tes or crea­te your own.
Using the tasks ‘Place­hol­ders’ and ‘Do­cu­ment crea­ti­on’ you spe­ci­fy which do­cu­ments the dos­sier must con­tain be­fo­re it can be released.
Do­cu­ments from your desk­top or from the file di­rec­to­ry can be used in the dos­sier. They are stored in the do­cu­ment ma­nage­ment sys­tem and used from the­re in one or more dossiers.
For each dos­sier, a main per­son re­spon­si­ble is iden­ti­fied, who also re­cei­ves the re­min­ders for com­ple­ti­on or pe­rio­dic re­view. In­di­vi­du­al chap­ters of the struc­tu­re can be trans­fer­red to a per­son par­ti­al­ly re­spon­si­ble for processing.
Do­cu­ments are ad­ded once to the con­tents list of the dos­sier and can then be in­ser­ted at several po­si­ti­ons in the struc­tu­re. Do­cu­ments can also be used in several dossiers.
When a dos­sier is re­leased, the ver­si­on is ‘fro­zen’, chan­ges are only pos­si­ble in a sub­se­quent ver­si­on. With the over­view ‘Ver­si­on sta­tu­ses’ you get an over­view of the do­cu­ment ver­si­ons. To ad­opt new ver­si­ons, crea­te a new ver­si­on of the dos­sier and de­ci­de which ver­si­on of the do­cu­ments to ad­opt. For do­cu­ments ad­ded to the dos­sier as at­tach­ments, the va­lid re­lease ver­si­on is al­ways used.
Prin­ting of do­cu­ments is pos­si­ble, the func­tion de­pends on the spe­ci­fi­ca­ti­ons from the do­cu­ment ma­nage­ment sys­tem (con­trol­led — not controlled).
Ex­port as ZIP ar­chi­ve or PDF file is pos­si­ble for the who­le dos­sier or for selec­ted chap­ters / documents.
For the ZIP file, the pro­tec­tion is pre­set with a pass­word. Fur­ther­mo­re, you can pre­set the crea­ti­on of PDF/A files to pre­vent prin­ting and co­py­ing and en­ter a wa­ter­mark for each export.
The ac­tions are re­cor­ded in the au­dit trail of the dos­sier, in­clu­ding the out­put as a ZIP or PDF file and the ex­port of in­di­vi­du­al do­cu­ments. The au­dit trail stores the date and time of an ac­ti­vi­ty for the ac­tions lis­ted be­low. Mo­reo­ver, the ID of the user trig­ge­ring the ac­ti­vi­ty is stored in the au­dit trail entry. 
Do­cu­ments can be in­ser­ted into the dos­sier re­gard­less of the file for­mat (PDF, MS Word, Ex­cel, Power­Point, PNG, JPG, TIFF, Visio)

Overview Medical Device Regulation (MDR)

The Ger­man equi­va­lent for the term  Me­di­cal De­vice Re­gu­la­ti­on (MDR) is “Me­di­zin­pro­duk­te­ver­ord­nung”. The Eu­ro­pean Uni­on (EU) Re­gu­la­ti­on 2017/745 will be­co­me bin­ding throughout Eu­ro­pe on May 26, 2021. In this ar­ti­cle you will find in­for­ma­ti­on on con­tent and im­ple­men­ta­ti­on re­gu­la­ti­ons for the me­di­cal tech­no­lo­gy industry.

Al­rea­dy on April 5, 2017, the “Re­gu­la­ti­on (EU) 2017/745 of the Eu­ro­pean Par­lia­ment and of the Coun­cil on me­di­cal de­vices” be­ca­me ef­fec­ti­ve. It re­pla­ces the pre­vious­ly va­lid “Di­rec­ti­ve 93/42/EEC on me­di­cal de­vices”. In con­cre­te terms, this me­ans for you in the me­di­cal tech­no­lo­gy sec­tor that EU Re­gu­la­ti­on 2017/745 su­per­se­des the fol­lowing ear­lier directives:

  • Me­di­cal De­vice Di­rec­ti­ve 93/42/EEC (MDD);
  • Di­rec­ti­ve 90/385/EEC, ac­ti­ve im­plan­ta­ble me­di­cal de­vices — Ac­ti­ve Im­plan­ta­ble Me­di­cal De­vices (AIMDD)

The EU bo­dies op­ted for a se­pa­ra­te re­gu­la­ti­on with re­gard to Di­rec­ti­ve 98/79/EC on in vi­tro dia­gnostic me­di­cal de­vices (IVD). This gui­de­li­ne did not find its way into the me­di­cal de­vice re­gu­la­ti­on. It will be re­pla­ced by the se­pa­r­ate­ly wor­ded EU re­gu­la­ti­on “In-Vi­tro Dia­gnostic Me­di­cal De­vices Re­gu­la­ti­on 2017/746 (IVDR).

In con­trast to the su­per­se­ded di­rec­ti­ve, the EU Parliament’s new re­gu­la­ti­on has gai­ned an in­ter­na­tio­nal pro­fi­le. Its bin­ding va­li­di­ty ex­tends to all EU mem­ber sta­tes from the key date of May 26, 2021. It should be no­ted here that as of Oc­to­ber 2019, no na­tio­nal le­gal acts have yet been adop­ted by the in­di­vi­du­al mem­ber sta­tes. This also ap­p­lies to Ger­man spe­ci­fics, re­qui­re­ments and pe­nal pro­vi­si­ons to be en­ac­ted. A cor­re­spon­ding draft for a Ger­man im­ple­men­ting law does exist. Ne­vertheless, the Fe­deral Mi­nis­try of He­alth an­ti­ci­pa­tes tran­si­ti­on periods.

Ac­cord­ing to the pre­sent text of the law, a tran­si­ti­on pe­ri­od of three ye­ars (05/26/17 — 05/25/21*) ap­p­lies du­ring im­ple­men­ta­ti­on. Af­ter the dead­line at the la­test, you as a ma­nu­fac­tu­rer are ob­li­ged to sub­mit an MDR cer­ti­fi­ca­te. This is the only way you are al­lo­wed to in­tro­du­ce a pro­duct to the mar­ket for the first time.

*In the wake of the COVID 19 pan­de­mic, the ef­fec­ti­ve date of the re­gu­la­ti­on was de­lay­ed to May 26, 2021 

In es­sence, the new re­gu­la­ti­on aims at an op­ti­mi­zed, uni­form re­gu­la­ti­on for the mar­ket launch of me­di­cal tech­no­lo­gy pro­ducts. The fo­cus is on the fac­tors of pro­duct safe­ty and pro­duct qua­li­ty.
For you as a mar­ket par­ti­ci­pant and user, the new EU re­gu­la­ti­on con­sists of a mix of fa­mi­li­ar con­tent from the pre­vious Di­rec­ti­ve 93/42/EEC and far-reaching chan­ges. Among the es­sen­ti­al, sub­stan­ti­ve and pro­ce­du­ral con­tent for you and your in­dus­try are the fol­lowing con­tents of the Brussels Regulation:

Ru­les for the clas­si­fi­ca­ti­on of me­di­cal de­vices
New terms and ru­les lead to chan­ges in the as­sign­ment of exis­ting pro­ducts to par­ti­al­ly mo­di­fied pro­duct clas­ses. For ex­amp­le, the pro­duct ran­ge of “stand-alo­ne” soft­ware is af­fec­ted by the­se changes.

Con­for­mi­ty eva­lua­ti­on pro­ce­du­re
Fol­lowing the set of ru­les for clas­si­fi­ca­ti­on, the con­for­mi­ty as­sess­ment pro­ce­du­re now also va­ries de­pen­ding on the class.

Tech­ni­cal Documentation/Document Ma­nage­ment Sys­tem
The tech­ni­cal do­cu­men­ta­ti­on ac­cord­ing to Me­di­cal De­vice Re­gu­la­ti­on pro­ves to be much more de­tail­ed. Be­ne­fits of con­trol and do­cu­men­ta­ti­on for the com­pa­nies be­co­me clear when loo­king at the new un­der­ly­ing ta­bu­lar sche­me in de­tail. The sub­di­vi­si­on into in­di­vi­du­al ca­te­go­ries in a di­rect link with the as­so­cia­ted de­tail­ed re­qui­re­ments forms the ba­sis for a de­tail­ed tech­ni­cal documentation.

Cli­ni­cal evaluations/clinical tri­als
Si­gni­fi­cant­ly in­cre­a­sed re­qui­re­ments cha­rac­te­ri­ze this ac­tion item. This ap­p­lies in par­ti­cu­lar to high-risk pro­duct groups.

Com­pa­ny responsibility/safety of­fi­cer
A si­gni­fi­cant chan­ge for your com­pa­ny re­sults from the re­qui­re­ment of the EU bo­dies for a re­spon­si­ble per­son in their or­ga­niz­a­ti­on to be ac­coun­ta­ble for re­gu­la­to­ry compliance .

Qua­li­ty ma­nage­ment
The FDA Me­di­cal De­vice 21 CFR 820 (FDA = U.S. Food and Drug Ad­mi­nis­tra­ti­on) sti­pu­la­tes the re­qui­re­ments for ma­nage­ment sys­tems of me­di­cal de­vice ma­nu­fac­tu­rers. In this func­tion, De­vice 21 CFR 820 is the coun­ter­part to ISO 13485. The core re­qui­re­ment is that pro­ce­du­ral in­st­ruc­tions such as do­cu­ment con­trol, pro­cu­re­ment, de­ve­lo­p­ment and pro­duc­tion are do­cu­men­ted and im­ple­men­ted analogously.

Mar­ket sur­veil­lan­ce me­cha­nisms
In par­ti­cu­lar, the man­da­to­ry use of the EUDAMED da­ta­ba­se pro­vi­des grea­ter trans­pa­ren­cy. It is avail­ab­le to both the pu­blic and di­rect com­pe­ti­tors as an in­for­ma­ti­on me­di­um. The cha­rac­te­ris­tics of each me­di­cal de­vice are map­ped by me­ans of ap­pro­pria­te links. Sup­ply chain tracea­bi­li­ty is also possible.

To fa­sci­li­ta­te time­ly com­pli­an­ce with the new re­gu­la­ti­on, you are cal­led upon to act, if you hold a re­spon­si­ble po­si­ti­on in your com­pa­ny. A co­he­rent plan for the tran­si­ti­on of your com­pa­ny to the Me­di­cal De­vice Re­gu­la­ti­on, both in terms of time and con­tent, is a pre­re­qui­si­te for your suc­cess. High prio­ri­ty should be gi­ven to the life cy­cles of your me­di­cal de­vice port­fo­lio. Exis­ting MDD cer­ti­fi­ca­ti­ons will lose their va­li­di­ty on May 26, 2024, ac­cord­ing to EU re­gu­la­ti­ons. Plea­se note in your plan­ning that your pro­ducts al­rea­dy cer­ti­fied ac­cord­ing to MDD must also com­ple­te the new con­for­mi­ty pro­cess to be es­tab­lis­hed ac­cord­ing to MDR. A “grand­f­a­the­ring” is not guaranteed.

In the tran­si­ti­on pha­se, you are par­ti­cu­lar­ly chal­len­ged in your func­tion as a ma­nu­fac­tu­rer or pro­vi­der. The hig­hest prio­ri­ty is to de­si­gna­te and train the per­son re­spon­si­ble for re­gu­la­to­ry com­pli­an­ce in your fa­ci­li­ty (MDR Ar­ti­cle 15). Up­dates to in­ter­nal qua­li­ty as­suran­ce pro­ce­du­res, do­cu­men­ta­ti­on, and mo­di­fied pro­duct clas­si­fi­ca­ti­on are mandatory

Against this back­ground, the fol­lowing stan­dar­di­zed pro­ce­du­re ac­cord­ing to the fol­lowing 4 points is recommended:

  • Im­ple­men­ta­ti­on of the con­for­mi­ty eva­lua­ti­on re­la­ted to the product
  • Com­ple­ting a de­cla­ra­ti­on of conformity
  • “CE” mar­king of products
  • Re­gis­tra­ti­on of com­pa­ny and pro­ducts in the EUDAMED database.

With the MDR, EU of­fi­cials have set out to crea­te a con­tem­pora­ry, uni­form so­lu­ti­on for qua­li­ty ma­nage­ment and mar­ket re­lease of me­di­cal de­vices. Gre­at at­ten­ti­on is paid to the qua­li­ty and safe­ty of pro­ducts. Perhaps you also be­long to the group of small and me­di­um-si­zed com­pa­nies in the me­di­cal tech­no­lo­gy sec­tor that fear over-re­gu­la­ti­on by the ex­ten­si­ve set of re­gu­la­ti­ons and ad­di­tio­nal au­di­t­ing bodies?

In par­ti­cu­lar, the eva­lua­ti­on of com­pli­an­ce by the “com­pli­an­ce ma­na­ger” to be re­crui­ted is li­kely to be­co­me a per­son­nel pro­blem du­ring the start-up pha­se. In a case of hardship, a shor­ta­ge of cer­ti­fied au­di­tors could de­lay the cer­ti­fi­ca­ti­on nee­ded for mar­ket re­lease. Me­di­cal tech­no­lo­gy in­dus­try as­so­cia­ti­ons ex­press fe­ars that a bot­t­len­eck in cer­ti­fi­ca­ti­ons could have a ne­ga­ti­ve im­pact on the mar­ket launch of in­no­va­ti­ve and mar­ket­a­ble products.

Customer reviews of Technical Documentation

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