mdi Europa spe­cial­izes on the ser­vices of an EU Autho­rized Rep­re­sen­ta­tive as laid down in the applic­a­ble EU leg­is­la­tion on med­ical devices. How­ev­er, our clients often require reg­u­la­to­ry ser­vices over and above this.

What our net­work offers

We have built a net­work of reg­u­la­to­ry affairs spe­cial­ists to present our clients all nec­es­sary ser­vices, which we as their reg­u­la­to­ry agency coor­di­nate on their behalf. For exam­ple, our net­work offers:

  1. Mar­ket entry and mar­ket devel­op­ment ser­vices in Europe
  2. Tech­ni­cal File compilation
  3. Com­pi­la­tion of qual­i­ty man­age­ment documentation
  4. Ser­vices with regards to WEEE and RoHS
  5. Trans­la­tion services
  6. Device approvals in the US/Canada
  7. Device approvals in Asia
  8. Device approvals in Latin America

Do you think you or your com­pa­ny will be a good match for our ser­vice port­fo­lio? We are always open to expand our net­work. Please get in touch.

Euro­pean Services

Besides CE Mark­ing, many addi­tion­al ser­vices may be required – such as trans­la­tions, mar­ket research, tech­ni­cal file com­pi­la­tions etc. This page pro­vides detailed infor­ma­tion on the ser­vices avail­able through our network. 

Who is part­ner in our Euro­pean network 

With a click on the com­pa­ny name in the fol­low­ing list, you can jump direct­ly to their pro­files on mdi Europa. Every pro­file is also linked to the company’s website.

WEEE Ned­er­land

Weee Ned­er­land is the biggest Dutch pro­duc­er com­pli­ance scheme spe­cialised in the col­lec­tion and prop­er treat­ment of waste of elec­tri­cal and elec­tron­ic equip­ment (WEEE) in the Netherlands.

Besides col­lec­tion and treat­ment Weee Ned­er­land also offers an EU con­sul­tan­cy ser­vice on WEEE, Pack­ag­ing and Bat­tery leg­is­la­tions. Since 1992 the high­ly moti­vat­ed and expe­ri­enced team offers its clients high qual­i­ty for a good price. Set aside qual­i­ty, also reli­a­bil­i­ty and trust­wor­thi­ness are val­ued com­modi­ties with­in our com­pa­ny. More than 600 pro­duc­ers and importers rely on our services.

Vis­it the WEEE Ned­er­land web­site to learn more

CPSL Lan­guage Services

CPSL Lan­guage Ser­vices is one of Europe’s lead­ing lan­guage ser­vice com­pa­nies, with near­ly 50 years of expe­ri­ence in man­ag­ing mul­ti­lin­gual projects. CPSL enables inter­na­tion­al com­pa­nies from dif­fer­ent indus­try sec­tors to effec­tive­ly com­mu­ni­cate their prod­ucts and ser­vices to glob­al audiences. 

Our ser­vices cov­er the full life­cy­cle of mul­ti­lin­gual gen­er­al and tech­ni­cal con­tent, start­ing with its cre­ation, the lin­guis­tic and cul­tur­al adap­ta­tion through to pub­lish­ing in dif­fer­ent for­mats and means of com­mu­ni­ca­tion. Among our ser­vices are: trans­la­tion; web and soft­ware local­iza­tion; DTP, elec­tron­ic pub­lish­ing and print­ing; inter­pre­ta­tion ser­vice, tech­ni­cal writ­ing, con­sul­tan­cy on inter­na­tion­al­iza­tion and local­iza­tion and many oth­ers. CPSL is an ISO 9001, ISO 13485, ISO 17100 and ISO 27001 approved com­pa­ny pro­vid­ing high qual­i­ty lan­guage solu­tions to more than 1,000 com­pa­nies on three continents.

Vis­it the web­site of CPSL Lan­guage Ser­vice to learn more

Klaas Con­sult­ing

Klaas Con­sult­ing is a Sales and Mar­ket­ing Con­sul­tan­cy, ded­i­cat­ed to assist­ing glob­al act­ing med­ical devices com­pa­nies in enter­ing all Euro­pean mar­kets, Turkey and Russia. 

Their main ser­vice is find­ing and man­ag­ing dis­trib­u­tors. In addi­tion they focus on reim­burse­ment, strate­gi­cal and oper­a­tional mar­ket­ing con­sul­tan­cy and on any mar­ket and mar­ket­ing researches.

Vis­it the web­site of Klass Con­sult­ing to learn more

Kan­zlei am Aerztehaus

The law firm “Kan­zlei am Aerztehaus” focus­es exclu­sive­ly on med­ical law. The office in Cologne is rep­re­sent­ed by law firm part­ners Alexan­der Maur and Andreas Frohn.

Being part of a high­ly spe­cial­ized team, they pro­vide the indus­try with com­pre­hen­sive advice – judi­cial­ly as well as from an eco­nom­ic point of view – cov­er­ing all aspects adher­ent to the law of med­i­c­i­nal prod­ucts and med­ical devices.

Vis­it the web­site of Kan­zlei am Aerztehaus to learn more

CE plus GmbH

Around the globe, CE plus GmbH assists com­pa­nies both large and small to suc­cess­ful­ly bring their med­ical device and IVD prod­ucts to mar­ket by pro­vid­ing expert reg­u­la­to­ry ser­vices and strate­gies through­out the prod­uct life-cycle.

CE plus GmbH pro­vides you with:

The prod­uct cat­e­gories we sup­port are:

Vis­it the web­site of CE plus GmbH to learn more.


Astra­Con offers strate­gic reg­u­la­to­ry con­sult­ing and qual­i­ty man­age­ment ser­vices for IVD and med­ical device companies. 

We help you to imple­ment MDR /IVDR require­ments in a smart way and stay up-to-date with reg­u­la­tions: reg­u­la­to­ry roadmaps, tech­ni­cal doc­u­men­ta­tion with inter­sec­tions to your QMS, clin­i­cal eval­u­a­tion reports, risk man­age­ment, clar­i­fi­ca­tion of OEM-PLM rela­tion­ship and qual­i­ty assur­ance agree­ments and much more. 

With Astra­Con you ben­e­fit from over 30 years of expe­ri­ence in the med­ical reg­u­la­to­ry field.

Vis­it the web­site of ASTRACON to learn more.

Inter­na­tion­al Approvals

Although Europe is one of the biggest med­ical device mar­kets world-wide, oth­er inter­na­tion­al mar­kets do not lose any of their impor­tance. We have thus iden­ti­fied the best spe­cial­ists world-wide to sup­port you, our client, in the most ide­al way. The fol­low­ing pages gives you an overview of ser­vices avail­able out­side the EU.

Who is part­ner in our inter­na­tion­al network 

mdi Con­sul­tants

mdi Con­sul­tants is a man­age­ment con­sult­ing com­pa­ny spe­cial­iz­ing in the med­ical indus­try since 1978. Staffed by for­mer FDA offi­cials and indus­try experts, mdi Con­sul­tants is a leader in the field of USFDA/EU/Health Cana­da reg­u­la­to­ry affairs and qual­i­ty issue. 

We assist with the CE mark under the new MDR, Health Cana­da Licens­ing and the MDSAP cer­ti­fi­ca­tion pro­grams. For FDA we pro­vide 510(k) reg­u­la­to­ry strate­gies, prepa­ra­tion and sub­mis­sions, clin­i­cal tri­als assis­tance, QSR/cGMP com­pli­ance and FDA trou­bleshoot­ing, com­pli­ance, reim­burse­ment assis­tance, project man­age­ment, and FDA/ISO/Internal audi­tor train­ing. US Agent and Offi­cial Cor­re­spon­dent ser­vices for for­eign com­pa­nies for FDA registration.

Vis­it the web­site of mdi Con­sul­tants to learn more

method sense

Meth­od­Sense  is deeply com­mit­ted to med­ical device and com­bi­na­tion prod­uct com­pa­nies.  We dri­ve intrin­sic busi­ness val­ue through qual­i­ty sys­tems, process and reg­u­la­to­ry strate­gies. And our peo­ple, process­es and tech­nol­o­gy improve both your busi­ness and teams. 

For 20 years, Meth­od­Sense has been assist­ing clients with FDA 510(k), de novo, and PMA applications. 

MethodSense’s core exper­tise and ser­vices include Cyber­se­cu­ri­ty Assess­ments, Human Fac­tors Human Engi­neer­ing / Usabil­i­ty Stud­ies, Risk Assess­ment and Risk Reme­di­a­tion, IEC 60601-1 3rd Edi­tion Prod­uct Safe­ty Test­ing Man­age­ment, 21 CFR Part 11 and Annex 11 Com­pli­ance Strate­gies, Ver­i­fi­ca­tion and Val­i­da­tion Devel­op­ment and Exe­cu­tion for tech­nolo­gies and man­u­fac­tur­ing process­es, Design­ing Soft­ware Con­trols for Com­pli­ance Needs, SDLC Method­ol­o­gy Opti­miza­tion, Tech­nol­o­gy Assess­ments for Pro­cure­ment or Acqui­si­tion.  We look for­ward to hear­ing from you:; +1 (919) 313-3960.

Vis­it the web­site of method sense to learn more

MD101 Con­sult­ing

MD101 was found­ed to assist med­ical device com­pa­nies in devel­op­ing and bring­ing prod­ucts to mar­ket, accel­er­at­ing time-to-mar­ket, and ensur­ing com­pli­ance with reg­u­la­to­ry standards.

With its large net­work of experts (45 in France, 30 world­wide), MD101 pro­vides mas­tery in a myr­i­ad of med­ical devices and is equipped to han­dle what­ev­er chal­lenge a man­u­fac­tur­er is fac­ing, whether it is qual­i­ty assur­ance, reg­u­la­to­ry affairs, clin­i­cal affairs, or reim­burse­ment strategy.

At MD101, we bring you the pow­er of our unique val­ue propo­si­tion, focused on healthtech, and the expe­ri­ence of a team that will ensure your business’s success.

Vis­it the web­site of MD101 Con­sult­ing to learn more

Cameron Mar­ket­ing and Communications

Cameron Mar­ket­ing and Com­mu­ni­ca­tions is a full-ser­vice New York agency that is devot­ed to dri­ving sales for our clients.

We have assist­ed over 100 US and inter­na­tion­al health­care com­pa­nies with prod­uct and cor­po­rate brand­ing, trade show and online pro­mo­tions, con­tin­u­ing edu­ca­tion pro­grams, Advocate/Opinion Leader devel­op­ment, online and print adver­tis­ing, and med­ical writing.

At Cameron Mar­ket­ing and Com­mu­ni­ca­tions, when we look at your busi­ness, we open our minds to oppor­tu­ni­ties you may not have con­sid­ered. Com­pet­i­tive advan­tages you may not have rec­og­nized. Sales mes­sages you may have over­looked. All to deliv­er return on your mar­ket­ing invest­ment you may not have imag­ined possible.

Vis­it the web­site of Cameron Adver­tis­ing to learn more

Vee Care (Asia) Limited

Found­ed by 2 sea­soned reg­u­la­to­ry experts from the Noti­fied Body Under­writ­ers’ Lab­o­ra­to­ries, Vee Care pro­vides a full range of reg­u­la­to­ry and com­pli­ance solu­tion for the glob­al med­ical device manufacturers. 

While Vee Care spe­cial­izes in reg­u­la­to­ry doc­u­men­ta­tion, qual­i­ty sys­tem set-up and device test­ing, its LCP divi­sion pro­vides glob­al mar­ket access solu­tions like coun­try rep­re­sen­ta­tion to device man­u­fac­tur­ers. Vee Care works close­ly with var­i­ous EU noti­fied bod­ies like BSI and reg­u­lar­ly holds reg­u­la­to­ry sem­i­nars on var­i­ous reg­u­la­to­ry top­ics. The Vee care team com­pris­es of experts from var­i­ous dis­ci­plines includ­ing IEC 60601 and ISO 11135.

Vis­it the web­site of Vee Care (Asia) Lim­it­ed to learn more