**************
We have worked with Qserve Consultancy to become a medical device company for our intelligent tube system solutions for the respiratory care industry. From the beginning of our collaboration we valued the open and interactive communication, not only on quality/regulatory related topics but definitively also the relation to strategic options. Qserve worked with us on our first product, the Hybernite rain out control system, preparing the FDA 510(k dossier) and CE marking technical file. Both clearances were obtained without any additional questions from the FDA or the notified body, respectively. During our ISO 13485 certification audit, we also achieved Annex II of the MDD, again “first-time-right”. It is due to the direct and no-nonsense approach of Qserve that we were able to achieve these goals on-time and within budget. Therefore, we continue to work with QServe in the future as our quality assurance and regulatory affaires partner.
Dr. Jenci Kurja, Global VP, Plastiflex Healthcare
**************
Op een scheidsvlak tussen medische apparatuur en farmaca is het zaak dat een jong bedrijf bij aanvang van ontwikkeling en zeker bij productie zorgvuldig omgaat met de regulatoire verplichtigen. Met Qserve hebben wij de ideale partner gevonden om ons daarin actief te begeleiden. Zowel qua advies als ook als mentor en sparring partner is dit een zeer belangrijke sleutel tot succes gebleken. De betrokkenheid met de doelstellingen en mogelijkheden binnen ons bedrijf is daarbij bepalend geweest. Ons advies is; “Begin vroegtijdig dan bespaar je zowel tijd als financiën.”
J.M. ter Riet CEO van MicroVision Medical Holding BV/Mediphenix Holding BV.
**************
As a fast growing product innovation company in the OTC market for medical device self care products, one needs a competent quality consultant who understands quality systems and understands business implications.
A consultant who keeps you on the right track in the developing regulatory jungle for medical devices around the globe, while keeping an eye on the business impact.
We've found this combination of competence in quality and in understanding of the business in Qserve.
We consider Qserve as our business partner, as an extension to our organization, not as a quality controller who only cares about strict implementation of the rules.
The Qserve staff are competent people, accurate and a pleasure to working with.
Rene van Eijkelenburg, CEO BioClin BV